#Submittal Stamp

[haveyoureadthisdcfic]

Authour: @a-canceled-stamp

Subfandom: Batman

Media: All Media Types

Relationships: Gen (Jason Todd & Tim Drake, Bruce Wayne & Jason Todd)

Year: 2021

Summary:

Jason is making an effort to try and fix things. It goes okay until it suddenly doesn't.

Submitted by @kiragecko

Submitter's comment:

Avoidance is easier than confrontation. Which means that Jason has a LOT to deal with once avoidance is no longer possible. It's quite inconvenient to be dealing with emotions while trying to figure out if you're also dealing with the dead body of a kid you never bothered to get to know!

[fictionalcanadianshowdown]

This is it folks! The round you've all been waiting for, the time we decide who is the ULTIMATE FICTIONAL CANADIAN.

It's been a tough battle. We have had over 70 contestants, spanning every province and territory expect the Northwest Territories. They've covered a variety of different mediums, from webcomics to video games to movies to poetry and more. Our oldest came from a poem published in 1847, while we also had one from a currently updating webcomic.

Of those figures, some towering figures of Canadiana, some more unknown (that I hope this blog helped get them a tiny little smidge of much deserved limelight) only two remain. Those are:

Anne Shirley is from Anne of Green Gables, a book by Lucy Maude Montgomery that has been turned into everything from a ballet to an animated children’s tv show. Anne has multiple museums, a theme park, two stamps from Canada Post and is a cornerstone of PEI’s tourism industry.

Anne is fanciful, imaginative, eager to please, and dramatic. She is also adamant her name should always be spelt with an "e" at the end

And

Toriko Nishina (blonde) is from Otherside Picnic a novel series/anime. From submitter: Silly lesbian who explores an alternate world full of internet creepypasta with her gf. knows a lot about guns. has two moms.

Who will win? Who will take home the poorly photoshopped crown?

[haveyoureadthisfanfic]

Summary: She'd woken up in an unrecognizable galaxy, jammed together from spare parts, a Cerberus logo stamped on her ass. She'd been handed a beautiful, expensive, top-of-the-line mockery of her old ship, crewed by beautiful, expensive, top-of-the-line terrorists. The Alliance wanted her to shut up and go back to being conveniently dead. Kaidan, it seemed, felt the same way. Anderson was the only family she'd ever had, and he wouldn't even answer her emails. And either Shepard's sanity had splintered under the stress, or she was now some kind of unkillable demigod. Or both.

Author: @meredithalden

Note from submitter: Amazing fic, great character voices and banter, does really interesting things with video game mechanics, honestly just read it!

[pixelsgarage]

hii!! could i pls request stamps and/or (no pressure) blinkies of damon maitsu and eva tsunaka from project edens garden? /nf thank you!!

I find making blinkies so much more enjoyable than making stamps, but I decided to make both because you seemed anxious about requesting. My inbox is open and I've made content for adjacent games before, don't be so hesitant!

I want to make it extremely clear for future submitters that any and all (non-violating) submissions matter to me; even when I'm worn out on a certain type of graphic, I'll always deliver!

[epic-song-lyrics-showdown]

Epic Song Lyrics Round 1, Wave 1, Poll 16

“Touch, sweet touch / You’ve given me too much to feel / Sweet touch / You’ve almost convinced me I’m real / I need something more / I need something…more.”

-Touch, Daft Punk ft. Paul Williams

“When the sharpest words wanna cut me down / I'm gonna send a flood, gonna drown 'em out / I am brave, I am bruised / I am who I'm meant to be, this is me”

-This is Me, The Greatest Showman

Touch-Daft Punk ft. Paul Williams

Time Stamp: 7:44-8:09

Propaganda:

One critique I saw of this song is that it is incredibly embarrassing…and it is. It is embarrassed, nervous, and most importantly, unabashedly human. This is a calm breath after an unrestricted showcase of emotion and feelings…taking a step back, and remembering that it seems like it’s not the time or place. It’s too late though. We can’t forget how incredibly vast love can spread.

This is Me-The Greatest Showman

Time Stamp: 0:46-1:01 and 2:01-2:16 on Spotify or 0:40-0:55 and 1:54-2:11 on YouTube here. (submitters preferred version)

Propaganda:

Listen, okay. It's been what, six years now since the movie came out? As a disabled queer person, this is still my instant ugly sobbing song.

Check out the other polls in this wave here.

[clinging-to-our-childhoods]

"Thank you, Stampy" Project still collecting Submissions!

Been a second since I last posted to Tumblr.

Hiya! I am currently collecting submissions for a video dedicated to Stampy Cat. You can share memories and stories, any fan art you may have, and a video/audio of you saying Thank you to Stamps. More details are in the form, and nothing is required.

I originally had the deadline set for August 11th, but at this point I will probably keep it open for any late submitters.

If you're interested in submitting, please do. And I'd love for you to share around, too!

Thanks for reading!

[deckbuildersoverlandpark]

What If My HOA Doesn’t Approve My Project?

When you live in a neighborhood governed by a Homeowners Association, you’re quite familiar with how rigid their rules can be.  It’s especially frustrating when you have your heart set on how you want your dream deck to look, yet you must work within the parameters set forth by the Powers That Be.

HOAs have “architectural control” over your house and property.       

HOAs exist for the express purpose of protecting the value of the homes in the neighborhood.  Their rules and regulations are put in place to prevent homeowners from altering aspects of their property that may be an eyesore to those around them.  After all, no home seller deserves to have potential buyers walk away or offer a lower price because the neighbor’s monstrous deck diminishes the expectation of privacy they should have in their own backyard.

When your HOA rejects your dream deck specs, you have two choices.

Modify your original deck design- Doing this can be heartbreaking, so try to stay focused by imagining the immense enjoyment the deck will bring you even though it might lack some of the sparkles you originally intended. 

Appeal the decision- If you believe the HOA is out of line and needs to be challenged, you’ll have to gather evidence demonstrating that you are in the right.  

Visit the county clerk’s office to verify that the HOA’s rules about deck construction have been properly recorded. If this is not the case, the regulations are unenforceable.

Talk to others in the neighborhood to find out if any of them have a similar deck design that was approved.

Find out how old the HOA covenants are because if they haven’t been updated since the 1970s, you may be able to get them amended. If you go this route, be sure to rally the support of your neighbors.

As you can see, dealing with the aftermath of the HOA’s denial can be a massive headache.

Save time and energy by avoiding the HOA’s Stamp of Denial!  

The last thing you need is your new deck becoming a reminder of the time you went into battle against your HOA.  To avoid turning your dreams of an outdoor retreat into a nightmare, there are a few things you can do.    

Before you draw up your ideal deck design, follow these steps:

Research the building permits from the county’s website- This is a good way to discover what the county will and won’t allow when it comes to decks.  Plus, proving to the HOA that you’re aware of all the permits that must be pulled following their approval is a smart move.  For example, if your design requires electrical work, it’s reassuring to them that you’re prepared to satisfy the county’s requirements by obtaining an electrical permit in addition to the building permit.

Research the HOA’s regulations regarding backyard decks- Knowing what is and is not allowed will help you design a deck that will receive the HOA’s Stamp of Approval.

Now that you know what is allowed per the HOA and the county, it’s time to move forward by creating a blueprint for an outdoor retreat that will give you years of pleasure and lasting memories.

Download and complete the HOA’s application-  Carefully fill out all pages and be sure not to leave any blank responses.  If you don’t understand something, get in touch with an HOA board member and have them explain it to you.  It can take the HOA up to 60 days to return their decision, so avoid doing anything that will cause a delay in their response.  They may even deny the application if it’s incomplete or filled out incorrectly.

Gain your neighbors’ approval- Have your next-door neighbors check out your deck design and, if they have no objections, have them sign a Statement of Approval that you can draw up yourself.  Demonstrating to the HOA that your neighbors don’t have a problem with your proposed deck will help sway the board members.

Submit detailed specs- Your HOA will want to know everything about the deck you intend to build, so be sure to include all the specifics such as height, width, building materials, and where it will be located on the property.

Once the HOA gives your deck design a thumbs up, make sure you get their determination in writing.  Should any problems arise, you’ll have proof that the original specs were indeed approved by the board.  There have been instances where an HOA has requested a deck be dismantled due to violations, so it’s best to save everything in a file in case your deck’s design is put to the test, which could happen many years after its construction.  

Relax! Leave it to the Experts of Kansas City Deck Projects.

Considering the strict protocols involved, it can be challenging to deal with the HOA’s Architectural Review Board.  All you want to do is enjoy a gorgeous deck, so why not take the pressure off by hiring a decking contractor who can deliver exactly what the HOA is demanding to see?

We at All Weather Decks will swiftly accomplish this and so much more!  Not only will we get your deck design approved during its first submittal, but we’ll happily pull the necessary permits as soon as we secure your HOA’s written endorsement.  On the topic of pulling permits, we don’t recommend that homeowners handle this task and encourage readers to check out this article to understand why.  By hiring us to handle all the red tape, you can be enjoying your dream deck while summer is still here! 

Reference Link: https://www.allweatherdecks.net/press-releases/home-owner-association-project-approval/

[bzuujogosonline]

Atone is a Global leader in construction management and Business Technology solutions. Atone provides a platform of features that allow all members of your team, from corporate owners to crew members the ability to communicate and work together effectively utilizing technology as a tool. With offline capability, you'll never miss any details in the field, any submittals completed will update once the network connection is re-established. Submittals and Project Specifications automatically sync to update real time analytics that allows large companies to assess their organization as a whole or drill down to the project specifics from anywhere.

+Capabilities

-Submittals

Bring your current submittals digital but keep the same PDF output your company is accustomed to using in the field.

Atone's powerful PDF output technology allows your company to seamlessly bring your paperwork digital.

-Tasking

Create Observations, Announcements, and assign tasks.

-RFIs

Keep RFIs Organized and accessible. Turn RFIs into actionable assignments.

-Punch List

Tackle Punch list items from the field with real time updates.

-Training

Distribute and coordinate training materials, media, and resources quickly and efficiently, Collect digital signature acknowledgements to verify completion.

-Orientation

Onboard hundreds of new employees more effectively with orientation in the palm of their hand.

-Timekeeping

Track project time and man hours in real time with time stamps and GPS locations.

-Audits

Perform audits more efficiently and send for review if necessary.

-Inspections

Track inspections down to the project, with GPS parameters to ensure inspections are happening in the correct location and during the designated time frame.

- Schedules & Meetings

Link team meetings, attend virtually, and visualize your schedule within one location.

-Project Specifications

Access plans, specs, and productivity from anywhere.

-Analytics

Collect important KPI's. Sort, Assess, and Analyze field data to improve productivity.

-Form Library

Keep PDF documents organized and at your fingertips to easily share in the field.

-BIM

View and Navigate 3D Models

-GIS

Location Based Asset Management

- Media

Capture Video, Audio, Photos, and Files.

-Contactless Signature

Capture Signatures in the field without sharing devices. #video #technology #data #team #digital #analytics #business #productivity #project #share

[epic-song-lyrics-showdown]

Epic Song Lyrics Round 1, Wave 3, Poll 4

“Thank you for the music, the songs I'm singing / Thanks for all the joy they're bringing / Who can live without it? I ask in all honesty / What would life be / Without a song or a dance, what are we?”

-Thank You for the Music, ABBA / Amanda Seyfried

Instrumental submission-Spider Dance, GameChops and Holder

Time Stamp: 0:29-0:52

Thank You for the Music-ABBA / Amanda Seyfried

Time Stamp: 0:41-1:03 or 1:53-2:15 or 2:48-3:10

Propaganda:

It's a celebration of music so what better lyrics for a tournament like this one?

Mod note: submitter preferred the Mamma Mia version.

Spider Dance, GameChops and Holder

Time Stamp: 0:29-0:52

Propaganda:

Just the build up and the drop is so good I absolutely love it. It also kinda feels like I'm drinking something I'm not supposed to be able to drink, that classic neon green liquid filled with bubbles or chemicals.

Check out the other polls in this wave here.

[little-p-eng-engineering]

Meena Rezkallah, P.Eng.

Jul 6

2 min read

Canada Piping Stress Engineer Services

Updated: Oct 6

StartFragmentAs a Canadian Engineering Company, the company are renowned for their expertise in the delivery of engineering projects, within the Oil and Gas industry. We proudly present our piping stress engineers capabilities to serve our clients.EndFragment

- Website Fonts (fonts.com) - Website Font Icons (icomoon)

StartFragmentEndFragmentOur Piping Stress Engineers possess extensive skills within the Oil and Gas Industry based in Canada. Our Piping Stress Engineers have experience of piping stress analysis including pipe support engineering and being focused on both core engineering whilst also managing and mentoring the flied needs in fabrication and erection stages. Our Piping Stress Engineers have professional engineering licences in Alberta, Saskatchewan, British Columbia and Ontario.

Our Piping stress Engineer capabilities (Duties and responsibilities):

StartFragment

Conduct pipe stress engineering of piping systems as per ASME, ANSI B31.3, B31.1, B31.8, B31.4, CSA Z662 code needs using Caesar II software  

Perform evaluation of nozzle loads or vessels stress utilizing WRC 107/297 capability of Caesar II program.  

Develop engineering computations and evaluations.  

Conduct complex engineering tasks along with key engineering work properly and efficiently.  

Ensure to extract engineering data from CAD drawings as well as computer models.  

Coordinate design of exclusive pipe supports as needed.  

Ensure to complete different assignments like drawings, parameters and varied materials apt for procurement plus construction purposes.  

Interact frequently with various engineering disciplines and departments.  

Develop detailed requisitions for pipe stress equipments and materials.  

Review vendor drawing submittals and conduct technical bid evaluation.  

Develop and issue parameters, data sheets and varied construction documents.  

Guide technically to CAD designer or drafters and engineers working on same pipe stress project.  

Perform as advisory facility to senior management staff on engineering pertinent matters.  

Support lead pipe stress engineer to develop and review pipe reinforcement job parameters.  

Is responsible for the quality, budget and respect of project schedule for piping stress analysis tasks  

Reviews the Client’s technical documentation and requirements  

Is responsible for the design of all piping supports components  

Issues project piping stress specification and critical lines list  

Performs calculations of critical piping networks  

Issues loads to allow the design of pipe-rack and foundations  

Issues technical part of requisitions for all piping supports components required by stress analysis calls for tender  

Issues technical bid evaluation for all piping supports components offers  

Issues technical part of requisitions for all piping supports components purchase orders  

Reviews and approve vendors documents  

Maintains project technical files and update Company standards  

Performs the inter-disciplines checking for the part of documents in accordance with the scope of piping material section  

Checks sub-contracted discipline engineering documents in accordance with the scope of piping stress section  

Checks documents issued by other piping stress engineers  

Checks the isometrics for construction of critical lines issued by the drafting office  

Assists P&ID’ section preparation for stress inputs of line list

Read More about our Piping Stress Analysis Services:

PIPING AND STRUCTURAL DESIGN VALIDATION SERVICES CALGARY ALBERTA CANADA  

Professional Engineering Verification and Sign-off Service Across Canada  

Piping Stress Analysis Services | Piping Packages Verification & Provincial Stamping  

Licensed Professional Canadian Piping Stress Engineer  

Piping Stress Engineer in Calgary Alberta Canada  

Meena Rezkallah

Located in Calgary Alberta Canada; We serve our clients across Canada and USA.

Please contact us now to get a free quote.

littlepenginfo@gmail.com

+1 (587) 802-4050

EndFragment

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[pmclorn11]

Consulting/CAD Services that specializes in providing quality low Voltage Systems CAD/Revit As-built CMC Communications also provides Consulting/CAD Services that specializes in providing quality low Voltage Systems CAD/Revit As-built documentation that caters to the needs and requirements of Low Voltage Cabling Contractors. CMC Has been in business since 2007 and has developed a client list Nationally. Our Goal is to provide the low voltage contractor with a quick turn around on accurate as-built documentation, leaving a professional lasting impression on the client as the Installers project comes to a close. The following is a list of our rates and services: Color or Black and White Plotting (50% Cost on projects we participate in) Close Out As-Built CAD Services – Rate 65.00 per hour Preparation of drawings for Manufacturer Certification Process Preparation of drawings for Owner/Client Close Out Documentation Drawings will include Outlet Labeling J-hook and Cable Tray Pathways (primary and branch) Symbols / Outlet locations (as-built) MDF/IDF enlarged plan (as-built) Backbone Pathway and Cable type (As-Built) Rack Elevations MDF/IDF Wall Elevations Pre-Construction Submittal Preparation – Rate 65.00 per hour TLD Design Consulting will take the material list, CAD files and the RFP requirements and generate a complete Pre-Construction Submittal package. CAD drawings will include J-hook and Cable Tray Pathways (primary and branch) Symbols/Outlet locations Proposed Backbone Pathway Enlarged MDF/IDF closet Plans Rack Elevations MDF/IDF Wall Elevations A binder will be prepared as required by the RFP with cut sheets of the material, items with multiple part numbers on a single cut sheet will be identified. Drawings will be plotted, bound and packaged neatly, then delivered to the Contractor for review (via courier or fedex) Revit / BIM Modeling Services – Rate $95.00 per hour RCDD Services - Site QA/QC inspections – Rate 125.00 per hour Conduct Project Site Walks to observe the following: Identify Potential Issues Pathway validation Conduit and Back box size and capacity Validation Standards Compliance Code Compliance Quality of installation TLD Design Consulting will prepare a 3rd party Site Observation report that can be presented by the Cabling Contractor to the client or the General Contractor in order to clarify or resolve on-site issues. Submittal Review and RCDD Stamp Services – Rate 125.00 per hour RCDD Services – Design Build/Consulting Services Can be provided in a separate proposal if interested We also provide the following services in Austin, San Antonio, Houston and Dallas areas: Professional Installation Services Network & Phone Cabling | IT Services | Phone Systems | Sound Masking | Fiber Optics | Cell Phone Repeaters & DAS Systems | Wireless Bridges | Audio | Video | Design Services | Certified Master Internet Re-seller for ISP | Cloud Managed Cisco Meraki & Ubiquiti Unifi Switches, Routers & Wi-FI systems | And More…Serving Austin, San Antonio, Houston, Dallas and surrounding areas. Please call 800-781-8431 or visit http://dlvr.it/Rbln4r

[thepurplehairedteacher]

From Spain to South Korea

Before I earned my 120-hour TEFL certificate at Canterbury TEFL (Madrid, Spain), I’ve wanted to move to South Korea to teach. After teaching two separate six month stays in the US, eight months in Riyadh, and five years in Spain, I have finally arrived in the Land of the Morning Calm.

I applied multiple times to different recruiters only to be rejected. There were those never acknowledging the receipt of my application. Some were kind enough to reply to my submittal. Sometimes the responses came with praise for my CV, but there seemed to always be a reason or another that I just couldn’t make the cut.

               “You need a minimum of three years of teaching in a school.”

“You don’t have enough teaching experience. You need five years.”

               “They’re usually looking for younger applicants.”

Throughout the years, I have spent many frustrating moments trying to handle the consistency of rejection.

Question: When you really, really want something, do you just give up on your dream because it’s been difficult and hard to obtain? Don’t get me wrong now. Sometimes, the Universe is trying to tell you, “It’s not for you.” One or two times I thought it, but I did not succumb to it

Whilst I loved living in Spain, and consider it home, moving to South Korea was something I still desired. Because ageism is real, I knew my window of opportunity was running out. So, I decided to give it one last try. Almost a year later of applying, I’m here in South Korea. Although I made it, it has not been an easy process.

Even after being accepted into the program, completing orientation, being placed, and starting at my new school, I’m still being pressed for verification. Just the other day, I received an email asking for contact information to authenticate an official document, which is on letterhead, with ink signature and stamped by the principal of the school I taught at for two years.

For a moment there, I felt myself becoming irritated, but what could I do? I did the only thing I could do, which was to shrug my shoulders, and send the requested information.

I reminded myself of the few affirmations I’ve written down to help guide me through as I try to acclimate to my new environment.

               Be gracious.

               Be kind.

               Be open minded.

               Ask questions.

Whilst my contract is only for one year, I am going to try and make the most of this opportunity to learn, grow, and enjoy.

[sfsucw]

Call for Alice James Award Submissions

Alice James Books is accepting submissions of poetry manuscripts to the Alice James Award (formerly the Beatrice Hawley Award) postmarked through November 1, 2017. The Alice James Award welcomes submissions from emerging as well as established poets. Entrants must reside in the United States.

Prize:

$2000

Book publication and distribution through Consortium

$1000 honorarium

A reading at the University of Maine at Farmington.

In addition to the winning manuscript, one or more additional manuscripts may be chosen for publication as the Editor’s Choice.

Fee: $30

Guidelines:

Screening for the Alice James Award is blind. Because of this, no contact information is allowed within your manuscript, including within the filename, if electronically submitted. Electronic submissions will have contact information collected via Submittable, which is hidden from our screeners. Hardcopy submissions must include a separate title page, which lists the title of your manuscript and contact information (name, address, e-mail address, and phone number).

Do not include any preambles, bios, or acknowledgements within your submitted manuscript.

Manuscripts must have a table of contents.

No illustrations, photographs or images should be included.

Manuscripts must be typed in a no less than 12 point font, paginated, and 48 – 80 pages in length (single spaced). We accept double sided manuscripts.

Individual poems from the manuscript may have been previously published in magazines, anthologies, or chapbooks of less than 25 pages, but the collection, as a whole, must be unpublished.

Translations and self-published books are not eligible.

No multi-authored collections, please.

MANUSCRIPTS CANNOT BE RETURNED. Please do not send us your only copy.

If electronic: send your manuscript via Submittable only with a cover page that lists the title of your manuscript. No personal/contact information is allowed to be included within your manuscript file.

If hardcopy: send one copy of your manuscript submission with two copies of the title page (one title page that includes just the title of your manuscript, the second which includes the title and your contact information [your name, address, phone number, e-mail address, and an optional biographical note)]). Use only binder clips. No staples, folders, or printer-bound copies.

For notification of winners, include a business-sized SASE.

If you wish acknowledgment of the receipt of your manuscript, include a stamped addressed postcard. Winners will be announced in April 2018.

Entry fee for the Alice James Award is $30 for online and hardcopy submissions. Checks or money orders for hardcopy submissions should be made payable to Alice James Books.

Manuscripts may be submitted online or by regular mail. Mail hard copy entries to: Alice James Books, Alice James Award, 114 Prescott Street, Farmington, ME 04938. For online submissions (open until 11:59 PM EST on 11/1), click here.

Submission:

One (1) copy of manuscript enclosed (NO CONTACT INFORMATION WITHIN MANUSCRIPT)

Electronic: Title page that lists only the title of your manuscript (NO CONTACT INFORMATION)

Hardcopy: Two (2) copies of title page (one page that shows only the title, the second which shows the title and your contact information)

$30 entry fee enclosed

Self-addressed stamped postcard for notification of manuscript

Self-addressed stamped envelope for notification of award winner

MORE INFO: http://alicejamesbooks.org/alice-james-award/

[meeraoperon]

Difference between FDA cleared vs FDA approved

FDA cleared vs FDA approved

is a significant capability between a drug and medical device. Given that undeniably more tech things are being checked by FDA, it’s basic to fathom the qualification.

Generally, “FDA approved” applies to drugs, however “FDA cleared” applies to “devices” and instruments. As a condition of clearness, things like number crunchers and plans that are used to make clinical decisions are considered “devices” in this particular situation, so even a mimeographed sheet used to work up a differential assurance with some check boxes on it is a “medical devices” that ought to be cleared by the FDA cleared vs approved (the standard is whatever replaces or instructs a point of view with respect to the demonstration with respect to drug).

We provide regulatory consulting of US FDA 510k for medical devices manufacturing.

We also assist with the establishment registration and device listings to make suitable the supply of medical devices in the US.

All manufacturers who try to showcase medical devices in the United States should initially pass an extremely exhaustive cycle with the FDA through one of two pathways—the section 510(k) measure, where a device is “cleared” for conveyance, or the Premarket Approval (PMA) measure, where a device is “approved” by the FDA.

Medical device organizations can utilize this pathway of FDA cleared vs FDA approved in the event that they can demonstrate considerable equality with a current item. The FDA analyst is assesses the data you give to “clear” your devices as like the predicate.

The PMA cycle, which ordinarily includes Class III devices, is considerably more thorough than the 510(k) measure. The devices need to demonstrate security and viability through clinical proof. This permits the FDA to put their stamp of “endorsement” on the devices.

It’s an obvious fact that Class II and Class III items are dependent upon different kinds of FDA investigations. FDA auditors can be probably the most conscientious individuals you will actually meet. They will look at your documentation intently, so you need to ensure you get the straightforward things, for example, phrasing, right.

What does FDA cleared vs FDA approved mean?

Clearance demands are for medical devices that are actually similar to those as of now available. Affirmed demands are for things that are totally new and should be investigated for security in the event of new perils. The two angles should be demonstrated or given by the submitter to guarantee legitimate methods are followed.

It implies that the office has established that the “advantages of the item exceed the known dangers for the planned use.” Manufacturers must present a premarket approval (PMA) application and the aftereffects of clinical testing so as to get approval.

When deciding to approve a product or drug, the FDA has to decide if the benefits outweigh the risks. The FDA is usually inclined to approve a product that has a higher risk if the potential benefit is significant — like an artificial heart valve that can save someone’s life.

FDA cleared or approved is usually mandatory to market or sell products in the US that might have a significant risk of injury or illness, but can also benefit your health — such as prescription medications, over-the-counter medications, vaccines and Class III medical devices.

The FDA categorizes medical devices into Class III, Class II and Class I. Complex medical devices that are implanted in your body, life-sustaining, or have the potential to cause significant injury or illness in the body are in Class III. Those include implanted pacemakers, replacement heart valves and even breast implants.

Lower-risk devices and products used outside of the body, like condoms, motorized wheelchairs and bandages, fall into Class II and Class I. For reference, Apple’s ECG app for the Apple Watch is in Class II.

This distinction is usually applied to medical devices. Medical devices are classified into 3 categories based on ease of use and risk in case of failure:

Class I: Low risk devices (e.g., bed pans, bandages, etc.)

Class II: Medium risk devices (e.g., pregnancy kits, glucose monitors, etc.)

Class III: High risk devices (e.g., pacemakers)

Accordingly, the stringency of regulations applied to get these devices to market varies from most relaxed to strictest. For a device to be FDA cleared or approved it only needs to show that it is comparable in performance to other similar devices already on the market. This is usually applied to Class II devices. However, for an “FDA approved” label, more extensive safety and effectiveness testing is performed before the device can be sold or marketed.

Read More -  

FDA cleared vs FDA approved

Visit Us -

Operon Strategist

Contact details –Phone no -  9325283428Mail  -

dm@operonstrategist.com

If  You Want Medical Devices Services Consultation For Following.

   1.    

Medical Device Manufacturing

   2.    

CDSCO Registration

   3.    

FDA 510 k clearance

   4.    

Continuous Improvement Program

   5.    

Design Control Requirements

   6.    

QMS Certification Services

   7.    

Manufacturing Plant Layout Design

   8.    

Primary Packaging Consultant

   9.    

CE Marking Consultant

 10.

Combination Product

11.

Medical Device Design And Development

 12.

Clean Room Design Consultant

13.

ISO 13485 Certification

14.

ISO 15378 certification

15.

Medical Device Process Validation

16.

21 cfr part 820

17.

21 cfr part 210 and 211

18.

DMF submission

19.

CAPA Management

20.

TURNKEY PROJECT CONSULTANT

21.

Manufacturing Site Conceptualization