#mdsap

[sushvin-consultancy-services]

[medgears]

ISO 13485 vs. MDSAP: What’s the Difference? 🤔

If you're in the medical device industry, you know compliance is everything. But do you need ISO 13485 or MDSAP—or both?

✨ ISO 13485 = The global gold standard for a quality management system (QMS). It ensures medical devices are safe, effective, and meet regulatory expectations worldwide. 🌍

🚀 MDSAP = A single audit that covers USA, Canada, Japan, Brazil, and Australia. Instead of multiple regulatory audits, one MDSAP audit satisfies them all. Talk about efficiency! ✅

ISO 13485 helps you build a strong QMS, while MDSAP makes global compliance smoother. If you're planning to sell in multiple markets, having both might be the key to success.

Are you working on certification? What’s been the biggest hurdle? Let’s chat! ⬇️

[avajosheph]

Gain global market access with MDSAP Certification, your key to streamlined compliance and international regulatory acceptance. In today’s world, selling your products globally can make your business successful. But, understanding all the rules and regulations in different countries can be really hard. That’s where MDSAP certification can help. MDSAP stands for Medical Device Single Audit Program. It’s like a super useful tool for medical device makers. It’s not just a simple “approved” stamp it’s more like a secret weapon that helps companies handle all the complicated rules and regulations easily.

[adamsbrown01]

The Medical Device Single Audit Program (MDSAP) is a harmonised approach to auditing and monitoring the quality management systems of medical device manufacturers on an international scale. The purpose of MDSAP is to establish, conduct and command a single audit program. This allows a single audit of a medical device manufacturer’s QMS which satisfies the requirements of multiple regulatory jurisdictions.

[amitkumarin]

What Is MDSAP?

The Medical Device Single Audit Program (MDSAP) is a harmonised approach to auditing and monitoring the quality management systems of medical device manufacturers on an international scale. The purpose of MDSAP is to establish, conduct and command a single audit program. This allows a single audit of a medical device manufacturer’s QMS which satisfies the requirements of multiple regulatory jurisdictions.

[alaskanathan]

ISO 13485 Mexico: A Comprehensive Guide to Medical Device Quality Certification

Introduction to ISO 13485 in Mexico

In Mexico's rapidly expanding medical device sector, ISO 13485 certification has become a vital benchmark for quality and regulatory compliance. ISO 13485 is an internationally recognized standard for quality management systems (QMS) specific to the medical device industry. It ensures that organizations consistently meet both customer and regulatory requirements applicable to medical devices and related services.

With Mexico emerging as a key player in the global medical device manufacturing market, compliance with ISO 13485 not only boosts credibility but is increasingly required to access international markets such as the United States, Canada, and the European Union.

This article explores the importance of ISO 13485 in Mexico, the certification process, key benefits, regulatory alignment, and why it’s becoming essential for medical device companies operating in the region.

1. What Is ISO 13485?

ISO 13485 is a QMS standard developed by the International Organization for Standardization (ISO), specifically designed for the medical device industry. It is based on the ISO 9001 framework but includes additional requirements related to risk management, sterile manufacturing, product traceability, and regulatory compliance.

Key features of ISO 13485:

Focus on risk management and product safety.

Emphasis on process validation and documentation.

Requirements for sterile product handling.

Alignment with global regulatory requirements such as FDA 21 CFR Part 820 and EU MDR.

Unlike ISO 9001, which applies to all industries, ISO 13485 is tailored for companies involved in the design, development, production, installation, and servicing of medical devices.

2. Why Is ISO 13485 Important in Mexico?

A. Rapid Growth of the Medical Device Sector

Mexico ranks among the top 10 exporters of medical devices globally, with over 2,500 companies in the sector, especially concentrated in Baja California, Jalisco, and Mexico City. Multinational companies and contract manufacturers are establishing or expanding operations in Mexico to benefit from lower costs, skilled labor, and proximity to the U.S. market.

B. Regulatory Alignment and International Trade

ISO 13485 certification facilitates access to:

U.S. FDA (via MDSAP – Medical Device Single Audit Program).

European Union markets (aligned with MDR requirements).

Health Canada and other regulators who recognize ISO 13485 under MDSAP.

Mexico’s Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) also considers ISO 13485 compliance a strong foundation for national sanitary registration.

C. Reputation and Trust

In an industry where patient safety is paramount, ISO 13485 signals commitment to quality, consistency, and continuous improvement. It reduces product recalls, improves customer satisfaction, and provides competitive advantage in both public and private healthcare markets.

3. ISO 13485 Certification Process in Mexico

Achieving ISO 13485 certification involves several key steps:

Step 1: Gap Analysis

Conduct an internal review of existing processes and documentation to identify what needs to be improved to meet ISO 13485 requirements.

Step 2: QMS Development

Develop or revise your quality management system, including:

Quality manual and procedures

Document control system

Risk management files

Supplier evaluation and control

Product traceability and feedback mechanisms

Step 3: Staff Training

Ensure that all employees understand the QMS and their roles in implementing and maintaining it. Training should include process controls, quality objectives, corrective actions, and regulatory compliance.

Step 4: Internal Audit

Conduct an internal audit to verify that your QMS meets ISO 13485 requirements and is being followed effectively.

Step 5: Management Review

Hold a formal management review meeting to evaluate the effectiveness of the QMS and make strategic decisions about improvements or resource needs.

Step 6: Certification Audit

Engage a recognized ISO certification body (e.g., BSI, SGS, TÜV SÜD) to perform a two-stage external audit:

Stage 1: Document review and initial assessment

Stage 2: On-site audit of operations and implementation

Step 7: Certification and Surveillance

Upon successful audit, you'll receive ISO 13485 certification, typically valid for three years. Surveillance audits are conducted annually to ensure continued compliance.

4. Integration with Mexican Regulatory Requirements

COFEPRIS Compliance

While ISO 13485 is not mandatory under Mexican law, it significantly aids in compliance with COFEPRIS requirements. COFEPRIS oversees the safety and efficacy of medical devices marketed in Mexico. ISO 13485:

Supports documentation for sanitary registrations.

Provides a solid foundation for Good Manufacturing Practices (GMP).

Reduces approval time for devices by demonstrating proven quality systems.

MDSAP Participation

Mexico is not currently a full participant in MDSAP, but companies operating in Mexico that export to the U.S. or Canada benefit from MDSAP certification. Since ISO 13485 forms the core of MDSAP audits, certification prepares firms to meet multi-country regulations with a single audit process.

5. Benefits of ISO 13485 Certification in Mexico

A. Improved Operational Efficiency

Standardized processes reduce waste, rework, and variability. Quality improvements lead to cost savings and higher product reliability.

B. Market Expansion

ISO 13485 certification is often a prerequisite to selling in regulated international markets. It builds trust with foreign buyers, regulators, and partners.

C. Risk Mitigation

The standard emphasizes proactive risk management in design and manufacturing, reducing the likelihood of adverse events, product recalls, and legal liabilities.

D. Brand Reputation

Being certified increases the credibility of your organization and products. It signals quality, compliance, and a commitment to patient safety.

6. Choosing a Certification Body in Mexico

When selecting a certification body for ISO 13485, consider:

Accreditation: Ensure the body is accredited by a recognized accreditation authority (e.g., EMA, ANAB).

Experience: Prefer bodies with experience in the medical device industry.

Local presence: Certification bodies with offices or auditors in Mexico reduce costs and scheduling delays.

MDSAP recognition: If you aim for MDSAP in the future, choose a certification body authorized to perform MDSAP audits.

Popular certification bodies in Mexico include:

BSI Group Mexico

SGS Mexico

TÜV SÜD America Inc.

DNV

Intertek

7. Common Challenges and How to Overcome Them

Documentation Overload

Many companies struggle with the documentation demands of ISO 13485. Use digital tools and QMS software to streamline document control, versioning, and approvals.

Resistance to Change

ISO 13485 may introduce new responsibilities and processes. Address this with strong leadership, communication, and regular training.

Cost Concerns

Certification costs vary based on company size and complexity but can be significant. However, the return on investment through improved efficiency and market access justifies the expense.

8. ISO 13485 for SMEs and Startups in Mexico

Small and medium-sized enterprises (SMEs) and startups are a growing segment of Mexico’s medtech industry. ISO 13485 offers them:

Structured quality processes from the start

Investor confidence, especially for venture-backed startups

Partnership opportunities with global OEMs

Startups should consider engaging a consultant or third-party service to speed up the certification process while maintaining focus on innovation.

9. Final Thoughts: Is ISO 13485 Worth It?

Absolutely. In the context of Mexico’s growing reputation as a medical device manufacturing hub, ISO 13485 is more than just a badge—it’s a business enabler. Certification opens doors to global markets, ensures regulatory compliance, and drives internal excellence.

Whether you're a multinational with operations in Tijuana or a startup in Guadalajara, ISO 13485 should be part of your growth and compliance strategy.

Get Started with ISO 13485 Certification in Mexico

If you're ready to begin the ISO 13485 certification journey, start by evaluating your current QMS, defining your goals, and choosing the right partners. With the right preparation and support, your organization can achieve certification and take its place in the competitive global medtech landscape.

iso 13485 mexico

[integrimedical]

SII invests in IntegriMedical’s Needle-Free Injection System technology

With this investment, SII will acquire a 20 per cent stake in IntegriMedical. Reportedly, the investment is expected to accelerate the development and commercialisation of the N-FIS technology

Serum Institute of India (SII), has announced an investment in IntegriMedical, acquiring a 20 per cent stake in the company, to advance Needle-Free Injection System technology.

IntegriMedical has developed a US patented Needle-Free Injection System (N-FIS) that utilises high-velocity jet stream using mechanical power to effectively and consistently administer biologics and drugs. The innovative drug delivery solution aims to alleviate pain during administration, providing needle-phobic patients with a pleasant and stress-free experience. IntegriMedical’s N-FIS has received regulatory approvals from CDSCO, CE, MDSAP and is ISO 13485 certified.

Read more@ https://www.expresspharma.in/sii-invests-in-integrimedicals-needle-free-injection-system-technology/

[mdsap1]

SAP Ariba Supplier offers digital commerce solutions and Ariba Network to connect over 3.4 million companies in 190 countries, helping buyers and suppliers discover new opportunities, collaborate on transactions, and grow relationships, thereby enhancing business operations.

[saudiarabia12]

Top MDSAP Consultants in the USA - Simplifying Compliance for Medical Device Companies

The Medical Device Single Audit Program (MDSAP) is a game-changer for medical device companies looking to streamline their compliance processes across multiple markets. The program allows a single regulatory audit to satisfy the quality management system requirements of several authorities, including the U.S. FDA, Health Canada, TGA (Australia), ANVISA (Brazil), and PMDA (Japan).

Engaging with expert MDSAP consultants in the USA, like Operon Strategist, can help medical device companies navigate the complexities of MDSAP audits and ensure smooth compliance. With their specialized support, you can achieve unified quality management systems and streamline regulatory processes, allowing for more efficient operations in multiple global markets.

Bookmark this to learn how you can simplify MDSAP compliance and improve your audit preparation with expert consultancy.

[shawnkilgarlin5]

Shawn Kilgarlin Speaks on Advancing Women’s Health at American Screening Corporation

American Screening Corporation incepted in 2004 is a pioneer in manufacturing and distributing rapid drug testing and medical supplies. Serving its clients for the last 20 years, ASC has grown to be a reliable concern with utmost satisfaction of all its customers spread over 27 countries.

Women are the backbone of any home and they play a crucial role in taking care of the welfare of the husband and children. They have to shoulder the responsibilities of a home along with her husband and take care of the education and health of her children. Hence it is very important that women should take care of their health. But women are prone to breast cancer, ovarian cancer, heart diseases, depression and anxiety. Therefore it is mandatory that women should give preference to their physical and mental health.

Shawn Kilgarlin’s Background:

Shawn Kilgarlin holds the post of the Vice-President of Sales and Marketing at American Screening Corporation. Formerly she was the Manager for Biotech at American Screening Corporation.

Shawn Kilgarlin is an eminent multifaceted personality and she is an Entrepreneur, Business Coach, Writer (ghost writer), Philanthropist, MDSAP Consultant and Drug Testing Manufacturer and has authored a book on ‘PAST TENSE’ along with her husband Ron Kilgarlin. The book enriches the mind of the readers with 365 Daily tools for putting stress behind for good.

Shawn Kilgarlin is much bothered about the health and well fare of women and strongly feels that they should involve in regular physical activity and exercise to avoid health issues. At the same time women should give priority to mental health by being optimistic and surround themselves with positive influences. Shawn Kilgarlin feels that women should set clear goals and pursue them and make use of the available opportunities to unlock their potential and improve their skills and talents. They should work towards maintaining a healthy nutritional diet and have minimum eight hours of deep and restful sleep. Periodically they should indulge in their hobbies and interests. These practices would certainly ensure that women maintain best health both at home and work places.

Women’s Health and Safety:

Women face lot of health issues related to reproductive health, malnutrition, maternal deaths and non-communicable diseases. Since they do not allocate time to take care of themselves and dedicate more time for the welfare of their husbands and children they tend to fall sick often. Women are affected by Breast Cancer, Ovarian Cancer, Depression, Heart Diseases, Fibroids and Cysts in Uterus and anxiety. Moreover women face a spectrum of health related issues such as adolescent pregnancy, irregular periods and some women face violence against them at home.

It is such a shocking fact that nearly 50% of the women have started taking alcohol and around 25% of them are addicted to drinking. Also few of them are addicted to consumption of Heroin. These practice cause health issues in women such as hormonal problems, menstrual issues, fertility problems, delayed pregnancy, breastfeeding issues and menopause problems.

To avoid health problems women has to Exercise Regularly, Sleep for 8 hours, Eat nutritional diet, Get Exposed to Sun, Quit Smoking and alcohol, Get Regular Health Check-ups, Be positive, Be thankful, Show gratitude and Indulge in Hobbies to avoid stress.

American Screening Corporation’s Contributions:

American Screening Corporation is an ISO 13485 manufacturer of FDA 510(K), CLIA waived Rapid Drug Testing Devices. ASC manufactures the highest quality products with highly competitive pricing. American Screening Corporation strives to fulfil its Mission, “We pledge to give you the ultimate in customer service and product support to meet your Drug Test, Point of Care and Medical Supply needs.” ASC holds its core values of Inspirational, Disciplined, Accountable, Execution, Aligned and Transparency to be the supreme ideal.

ASC distributes Drug Test Kits, which uses Urine, Blood, Saliva, Hair and Sweat to screen for prohibited drugs and alcohol. ASC manufactures Drug Test Specimen Cups, 4 Panel to 20 Panel Drug Test Cups, Urine Test Kits, Alcohol Test Kits, Medical Test Kits, Pregnancy Test Kit, Oral Swab Drug Test Kit, CLIA Waived Saliva Drug Test Kits, Urine Dip Stick, Specimen Collection Kits, Drug and Alcohol Testing Breathalyzers and Home Drug Test Kits along with Medical Supply, Nitrile Gloves and Earloop Mask.

ASC’s Diagnostic tools like Urine Specimen Cups are very useful in treating patients affected by urinary tract infections, kidney diseases and diabetes. Another efficient tool is the Vacutainer used in collecting blood samples without syringes and works on the principle of negative pressure.

Specifically for women’s health Pregnancy Confirmation Kits and Ovulation prediction Kits are available with ASC along with other testing kits.

The most common specimen used for alcohol detection is human saliva and ASC’s Alcohol Saliva Testing Strips come with simple instructions which make it convenient for anyone to administer the test.

Alcohol Urine Testing Strips are very suitable because of its high accuracy. EtG urine alcohol test is a highly advanced test as per the modern trends which show results of Ethyl Glucuronide. The metabolite of alcohol EtG, is easily detectable in the urine sample which screens the presence of alcohol up to 4 days.

ASC’s Drug Test kits are CLIA Waived and FDA(510k) approved. They are highly reliable and come with 99% accuracy. They are made up of premium quality medical grade plastic and tamper proof. They are leakage free and user friendly. ASC offers great discounts for bulk orders and hence they relatively come with low cost.

Importance of Drug Testing Kits

Drug Testing Kit is used for screening illicit drugs and substances of abuse which are consumed by people. These drug testing kits are very important because usage of drugs by the employees raises questions of work place safety and security. Also when people come to work after consuming drugs, it causes a potential risk to the public, especially in the transportation and construction business. Apart from this it spoils the brand name, dignity and decorum of the concern.

ASC is the leading manufacturer, distributor and stockist of Drug Test Kits which has its warehouse in Shreveport, USA. The most frequently sought out instant drug testing kits are multi panel test cups like 5 Panel , 7 Panel , 10 Panel , 12 Panel, 14 Panel and 20 Panel. Out of the entire range, the 5 panel, 10 panel and 12 panel drug testing kits are mostly purchased and used.

Types of drug testing kits available

Urine drug test is the easiest and quickest way of detecting substances in the urine sample. The urine sample of the individual has to be collected in the urine drug test cup and after 5 minutes, the level should be peeled off from the cup. The urine drug test cup contains two strips one for adulteration and the other for temperature. Within next five minutes, result is easily displayed whether it is positive or negative.

Oral saliva drug test is used for drug testing, because collecting the saliva of a person is relatively easier which does not require privacy and is relatively convenient because they are less invasive, user friendly, quick and efficient and are mostly used in on-site workplace oral swab drug testing. The saliva oral drug test kit consists of an absorbent pad to collect the saliva. The saliva is made to flow along the test kit. This saliva sample has to flow up to control line for the screening is to be done. Wait for 5 minutes to analyse the result. The presence of a line in the testing kit indicates a negative result and the absence of line in the kit denotes a positive result.

Hair drug tests provide a longer detection window, typically spanning several months. This is because drugs and metabolites become incorporated into the hair as it grows. A small hair sample is collected from the individual’s scalp or body during a hair drug test. The sample is then analyzed in a laboratory to detect the presence of drugs or their metabolites. Moreover collecting hair specimen is the easiest of all tests and does not require privacy.

Regular and periodic drug testing at work places, institutions and at home gives a sense of responsibility, motivates a person to stay away from drugs and help them to follow a disciplined life.

Shawn Kilgarlin’s Advocacy and Initiatives

Shawn Kilgarlin strongly believes that women should have an easy access to health care and testing owing to the reason that they are always busy in taking care of their family and do not have enough time to go for a health facility. Also they should undergo periodic health check up at least once in a year to prevent health issues.

Shawn Kilgarlin has joined hands with the Shreveport community in uplifting the life of women. One such programme is providing free health check up to women and free pregnancy test. Also ASC is involved in giving skill training, child caring and career guidance to women. Women are offered free counselling for their physical and mental health. On the whole ASC focuses on a stress free, successful life to women.

Success Stories and Impact

The women at Shreveport are thankful to ASC for offering free health check up and pregnancy test. The community is filled with gratitude for uplifting their life through skill training and assisting them to identify and pursue their career according to their education and area of interest. Also free counselling and guidance session is available for women to find a solution to their problems.

Using American Screening Corporation’s medical tools regularly at work places, health facilities, educational institutions and rehabilitation centres help the individuals to check out their habits and to realize when the habit is going beyond limit. This checking enhances the nature of the individuals to stay away from alcohol and harmful drugs.

Future of Womens Health and Safety in Healthcare

Artificial intelligence plays a significant role in healthcare and there is almost no area of medical care where AI cannot be used. Starting from diagnosing a disease like cancer and up to its treatment using radiotherapy AI helps the human kind by its accurate application. Also AI is used in Eye Care, Pregnancy test, Ultrasound Scanning, CT Scanning, ECG, Cardiology, MRI and Plastic Surgery and indeed very helpful for patients undergoing treatments. Shawn Kilgarlin is very sure that in a very short time AI would be replacing many of the roles in a healthcare industry and that would surely be highly beneficial to the people. This adoption of AI will certainly change the scenario of medical diagnosis and treatment in hospitals and clinics.

American Screening Corporation is of the opinion that since AI is capable of interpreting a huge amount of data, can detect health problems quicker, give personalized treatment, automate processes and discover drugs, it is time to incorporate AI in all our products and innovation. The future of AI is filled with promises and possibilities for improvement and innovation and that is going to be an asset to medical industry. Hence the future of ASC is to completely adopt AI in drug testing for a healthy and happy life.

Conclusion

Women play an important role in the family and hence they should take care of their health. Periodic health check up helps them to prevent health issues. Also by exercises, healthy diet, restful sleep, indulging in hobbies and avoiding alcohol and drugs helps them to maintain best of health.

Women should undergo regular blood testing, vaginal testing and breast testing periodically to check their cholesterol level, blood pressure, heart condition, blood sugar and uterus health.

[adamsbrown01]

Navigating MDSAP in Australia: A Comprehensive Guide

Introduction

In the ever-evolving landscape of medical device regulation, manufacturers face various challenges in ensuring their products comply with the strictest standards. One such challenge is the Medical Device Single Audit Program (MDSAP), a globally recognized initiative aimed at harmonizing regulatory practices among participating countries. For medical device manufacturers seeking to market their products in Australia, MDSAP is a crucial aspect of the regulatory framework to understand and comply with. In this blog, we will delve into MDSAP in Australia, exploring what it is, its significance, and the steps to ensure compliance.

What is MDSAP?

MDSAP, the Medical Device Single Audit Program, is an international program established to promote harmonized medical device regulatory processes across multiple countries. The program allows medical device manufacturers to undergo a single audit, which satisfies the requirements of participating countries, eliminating the need for multiple audits in each country. Australia is one of the participating nations in this program.

The Significance of MDSAP in Australia

Australia's Therapeutic Goods Administration (TGA) is responsible for regulating medical devices in the country. MDSAP plays a significant role in the TGA's regulatory framework. Here are a few key reasons why MDSAP is crucial for medical device manufacturers in Australia:

1. Streamlined Auditing: MDSAP allows manufacturers to undergo a single audit process that satisfies multiple regulatory authorities, including the TGA. This streamlines the auditing process and reduces the regulatory burden for manufacturers.

2. Global Market Access: Compliance with MDSAP standards enhances the market access of medical devices, as many countries recognize the program. This opens doors to international markets for Australian manufacturers.

3. Regulatory Alignment: MDSAP aligns regulatory practices and expectations among participating countries, ensuring that medical devices meet consistent standards for quality and safety.

Steps to Ensure MDSAP Compliance in Australia

Complying with MDSAP requirements is a critical step for medical device manufacturers looking to enter the Australian market. Here are the steps to ensure MDSAP compliance:

1. Familiarize Yourself with MDSAP Requirements: The first step is to understand the MDSAP requirements and how they align with Australia's regulatory framework. The TGA's official website and MDSAP documentation are valuable resources for this.

2. Select an Authorized Auditing Organization: To undergo a MDSAP audit, you must choose an authorized auditing organization that is recognized by the TGA. Ensure the auditing organization has experience in medical device regulations and international standards.

3. Prepare for the Audit: Work closely with the selected auditing organization to prepare for the audit. This includes conducting internal audits, gathering necessary documentation, and ensuring that your quality management system complies with MDSAP standards.

4. Undergo the MDSAP Audit: The audit process involves a comprehensive evaluation of your quality management system, documentation, and procedures. The auditing organization will assess your compliance with MDSAP requirements.

5. Address Findings and Recommendations: If any non-conformities or recommendations arise during the audit, address them promptly. Corrective actions are essential to maintain compliance.

6. Submit the Audit Report to the TGA: After a successful MDSAP audit, submit the audit report and any necessary documentation to the TGA for review and certification.

7. Maintain Ongoing Compliance: MDSAP compliance is an ongoing process. Stay up-to-date with regulatory changes and ensure your quality management system continues to meet the required standards.

Conclusion

MDSAP certification is a critical component for medical device manufacturers seeking to navigate the Australian market successfully. By understanding the significance of MDSAP certification and following the outlined steps, you can streamline your entry into Australia, reduce regulatory burdens, and expand your market reach globally. Remember that compliance with MDSAP requirements is an ongoing process, requiring vigilance and adaptability to stay aligned with evolving regulatory standards in Australia and beyond. Obtaining MDSAP certification is a significant achievement that can significantly enhance your competitiveness in the global medical device industry.

[amitkumarin]

MDSAP is a technique through which medical device makers may be inspected once for conformity with the different medical device markets standards and regulatory requirements. Multiple individual audits or inspections by participating regulatory bodies or their representatives are replaced by a single audit. As a result, the Medical Device Single Audit Program minimizes the overall number of audits or inspections and optimises the time and resources spent on audit operations for many medical device manufacturers.

[sudheervanguri]

Internship Opportunity Bangalore Beckman Coulter Life Sciences Apprentice Trainee - Quality Control - B Pharm, M Pharma, Bsc, Msc Liesciences Beckman Coulter Life Sciences is dedicated to empowering those who seek answers to life's most important scientific and healthcare questions. With a legacy spanning over 80 years, we have established ourselves as a trusted partner for customers around the globe. Our mission is to accelerate scientific discoveries and improve human health through innovative solutions. Role and Responsibilities We are currently seeking Apprentice Trainees for our Quality Control department at the Bangalore Development Centre. As an Apprentice Trainee, you will be responsible for performing day-to-day activities in the Quality Control function, ensuring compliance with various quality standards, including 21 CFR 820, ISO 13485, ISO 9001, and MDSAP. Key responsibilities include: Conducting routine analysis of raw materials, in-process, and finished formulations according to Standard Operating Procedures (SOPs). Compiling data for documentation of test procedures and preparing reports. Performing and overseeing calibration and maintenance of lab equipment. Reviewing data for compliance with specifications and reporting abnormalities. Revising and updating SOPs. Ensuring lab cleanliness and safety standards are maintained. Performing inspections of incoming, in-process materials, and finished products. Participating in and performing investigations related to QC testing. [caption id="attachment_84046" align="aligncenter" width="1200"] Beckman Coulter Life Sciences as an Apprentice Trainee in Quality Control[/caption] Qualifications and Experience To be eligible for this internship, candidates should possess the following qualifications: Bachelor's degree with 2+ years or Master's degree with 0-1 year of related experience in B Pharm, M Pharm, BSc, or MSc Life Sciences. Preferred qualifications include: Knowledge of ISO 9001: 2015 and ISO 13485: 2016 requirements. Strong communication skills (verbal, written, presentation, and relationship building). Ability to work collaboratively and drive results. Capability to handle pressure and provide constructive feedback. How to Apply If you are interested in this exciting internship opportunity, please apply online through our career portal. Visit Danaher Careers to submit your application.