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Yo, as a medical device translation specialist, I just finished a big project: translating a 2023 Annual Risk Management Report for an ultrasonic surgical system from Chinese to English. Thought it was gonna be a regular gig, but nah, it was a real wake-up call. In this game, every single word is a matter of life and death.

Here's what this project taught me about the high-stakes world we play in, the stuff you don't see:

1.  Terminology Ain’t Just Words—It’s a Freakin' Safety Protocol    The Chinese term “超声刀头” was first translated as “Ultrasonic Cutter Heads.” But after checking the FDA’s Recognized Consensus Standards Database, I found the ISO-certified term: “Ultrasonic Scalpel Blades” (ISO 13485:2016).

   Why it matters:

   If you mess up the labels, you're asking for regulatory trouble.

   A client got delayed during a 2022 EU MDR audit because “手柄” was translated as “handle” instead of the EUDAMED-registered term “Handpiece Assembly”.

2.  Data Precision: Where 0.01% ≠ “Negligible”    The report showed 86 adverse events (0.097% of 88,716 units sold). Translating this required:

   Triple-checking decimal points (0.097% vs. 0.97% could mean a 10x risk difference)

   Contextual footnotes explaining “组织垫熔融” not just as “tissue pad melting” but specifying “thermal degradation due to prolonged activation (>10s)”

   Real-world example: In 2019, a mistranslation of “<0.1% failure rate” as “0.1% failure rate” in a cardiac device manual led to a Class II FDA recall.

3.  Cultural Fluency in Regulatory Narratives    The Chinese original focused on compliance with GB 9706.1-2020 (China’s medical electrical equipment standard). For the rest of the world, this meant:

   Equivalence mapping: Linking GB 9706 clauses to parallel IEC 60601-1 requirements

   Risk communication adjustment: While the Chinese report prioritized process controls (“生产过程悬浮粒子监控”), the translation highlighted patient outcomes (“No non-conformities in microbial testing”) to align with EU MDR’s Article 88.

4.  The Hidden Challenge: Translating “Silent” Risks    One section described “激发失效” (excitation failure). The direct translation didn’t cut it. After talking with the client’s engineers, we rephrased it as:

   “Inconsistent Transducer Energy Output (Code E12): May cause inadequate tissue sealing, potentially leading to delayed bleeding (See IFU Section 4.3)”

   This matched the FDA’s Human Factors Engineering guidance on labeling foreseeable misuse.

   “3手柄破损案例中，1件因超寿命使用导致”    (“3 handpiece fractures, 1 caused by exceeding recommended lifespan”)

   This ain’t just data—it’s a patient on the operating table. As medical translators, we’re not just translating words; we’re co-authoring safety narratives.

   Let’s get behind:

   Certification programs like ISO 17100 for medical devices

   Collaborative platforms for translators to flag ambiguous source text

   Ethical pricing models that enable the rigor this work demands

   Discussion:

   How do you balance client glossary preferences with regulatory terminology?

   Should medical translators get some basic clinical training?

   \#MedicalTranslation \#MedTech \#RegulatoryAffairs \#PatientSafety

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📚 Lost in (Medical) Translation: How I Survived Translating an FDA Drug Label 🌡️✨

1. The Day I Met “Myelosuppressive”

Caption: “When ‘myelosuppressive’ isn’t just a tongue-twister—it’s a life-or-death term. 🔍 EN: myelosuppressive anti-cancer drugs 🔍 CN: 骨髓抑制性抗癌药物 But wait—does it mean the drug causes suppression or treats it? Spoiler: Google Translate tried to kill this patient. (Just kidding… mostly.)

2. Data Drama: Why 12% ≠ “About 10%”

Caption: “Translators don’t round numbers. Ever. 📉 Fact: A 2% difference in ‘thrombocytopenia’ rates could mean skipping a lifesaving drug. 💡 Pro Tip: If your client says ‘just estimate,’ RUN. 🏃♀️💨”

3. Tools of the Trade (That Won’t Bore You)

Caption: “My survival kit for translating Ryzneuta: ☕ Caffeine: Mandatory. 📖 WHO Drug Dictionary: Because ‘glomerulonephritis’ isn’t a Harry Potter spell. 🖥️ Trados: For when autocorrect tries to turn ‘neutropenia’ into ‘neutron pizza.’ 🍕”

4. When Warnings Need a 🔥 Makeover

Caption: “FDA labels are low-key horror stories. 💀 Before: ‘Discontinue if splenic rupture occurs.’ 💀 After: ‘STOP OR YOUR SPLEEN MIGHT EXPLODE 💥’ (Not FDA-approved but way more fun.)”

5. “Oops, I Translated ‘Injection’ as ‘Stab’”

Caption: “True story: I once turned ‘subcutaneous injection’ into ‘skin stabbing.’ 🩸 Moral: Always triple-check—or risk becoming a viral meme. 🐱🚑”

Tags: #MedicalTranslation | #LostInTranslation | #PharmaNerd | #TranslatorStruggles | #FDA | #Ryzneuta | #NicheHumor

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Decoding Technical Translation: Lessons from Avantor’s SAP Upgrade and Batch Numbering Overhaul

Yo, when a big dog like Avantor, a materials science G.O.A.T., upgrades its SAP system and messes with batch numbers, it ain't just an IT thing, ya dig? It's a masterclass in tech comms and translation finesse. As a translator, breakin' down these docs gives you the keys to unlock language barriers while keepin' the tech stuff tight. Let's get into how to handle terminology, coding, and formatting to make sure everyone's on the same page, globally.

1.  Terminology: The Art of Industry-Specific Localization    Case Study:

   Original Term: Certificates of Analysis

   Literal Translation: "Analysis Certificates" (❌ Sounds sus in regulated industries)

   Optimized Translation: "Certificates of Analysis" (✔️ Keep it for compliance) or "Test Reports" (depends on the context).

   Key Insight: In places like pharma, where the rules are strict, you gotta stick to standards like ICH or GMP. Mess up and translate "Qualified Person" as "Certified Individual" (instead of "QP" or "质量受权人" in Chinese)? You're askin' for trouble.

   Strategies:

   Build glossaries with tools like SDL Trados, puttin' the client's terms first.

   Check against industry standards (ISO, FDA) to make sure you're right.

   Use AI with caution—GPT-4 drafts need a human touch to get the meaning right.

2.  Encoding Logic: Turnin' Code into Clarity    Avantor’s Batch Number Format: YYMDD@XXX

   Breakdown:

   YY: Year (e.g., 21 = 2021)

   M: Month code (A=Jan, J=Oct, L=Dec)

   DD: Day

   @@: Plant code (61=Paris, KY; 62=Phillipsburg, NJ)

   XXX: Sequential counter

   Translation Challenges:

   Symbol Retention: Keep the symbols (like @@, XXX) so things don't get confusing.

   Visual Aids: Use tables to show the letter-month codes (see Fig. 1) and explain the weird stuff (like "L=December").

   Example Localization:

   Original: "21J0661001" → Translated explanation: "2021-Oct-06, Paris Plant (61), Batch 001."

3.  Formatting: The Silent Ambassador of Professionalism    Common Pitfalls & Solutions:

   Tables all messed up: A broken "Tech nical.Service" in contacts looks amateur.

   Fix: Use Markdown/LaTeX for alignment; check with tools like Adobe Acrobat.

   Punctuation all over the place: Mixed EN/CN commas mess up the flow.

   Fix: Use AI tools (e.g., iThenticate) to catch it automatically.

   Three-Step Quality Assurance:

   Content Layer: Check dates, codes, and contacts against the original.

   Logic Layer: Make sure the tech stuff makes sense (like plant codes match locations).

   User Experience Layer: Make it easy to read—bold key terms, break up complex rules.

4.  The Translator’s Toolkit for Technical Documents    Terminology Management: SDL Trados, memoQ

   Encoding Validation: Regex101, Notepad++

   Formatting: Pandoc (multi-format conversion), Grammarly (punctuation consistency)

5.  Why Human Translators Still Matter in the AI Era    AI can get you started, but you still need a human for:

   Contextual Judgment: Knowin' when to keep terms or translate them (like "SAP system" usually doesn't need translation).

   Risk Mitigation: Catching small errors like "tracking" vs. "traceability."

   Cultural Nuance: Adjusting examples (like explaining "Paris, KY" to people who ain't from the U.S.).

   Engage & Learn    🗨️ Discussion Prompt:

   What's the hardest tech document you've translated, and how'd you make sure it was right?

   How do you balance AI speed with human accuracy in your work?

Visual Appendix

Fig. 1: Letter-Month Code Table (A=Jan, J=Oct, L=Dec)

Fig. 2: SAP Workflow Diagram (Pre- vs. Post-Upgrade)

Hashtags: #TechnicalTranslation #Localization #SupplyChain #SAP #Pharmaceuticals #Compliance

   Tech translation ain't just about words—it's about connectin' systems, cultures, and rules. In this global game, gettin' it right ain't optional; it's how you survive.

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Fifty days after Deepseek dropped, I switched lanes and kept it movin'.

Early March, one morning, the HR from a translation company I was workin' with hit me with a message: "Yo, we're pushin' machine translation and proofreadin' now, and we wanna talk rates. Machine translation is 50% of the original translation cost (that's if the base text is machine-translated), and proofreadin' is 30% (if the base text is human-translated or a second machine translation review)."

—That moment? I heard the unemployment clock tickin'. ⏳

After a week of sweatin' it, I flipped the script: human-AI hybrid mode activated.

① "Use AI to beat AI" – a modified Trados + Deepseek plugin setup, lockin' Deepseek into "terminology slave" mode, hijackin' its processin' power for my benefit.

② Aggressive job huntin': My resume got a new section: "Human Proofreadin' Value Assessment."

After hittin' up over 100 translation companies, I saw the dark side of the forest:

① Not every translation company is ditchin' human translation for the sake of cost.

② Whether it's translation or proofreadin', the highest bidder wins. You're still workin' for somebody.

Hit me up with a private message for a "Survival Guide," and I'll send you a weapons kit: 50 translation company email addresses, free for a limited time.

Now, my new title is: AI-Human Liaison Officer. My hourly rate is up three times what it was when I was just translatin', because I can use Deepseek to handle 80% of the basic work, and use my human smarts to protect the 20% core value zone.

You think AI is gonna kill the translation game?

A. Gone in three years

B. Value's gonna get reshaped

C. The strong get stronger

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Yo, check it: About a month back, the project lead, he slides me two PowerPoint decks on elevator monitoring systems, right? And demands a Chinese-to-English translation in, like, two days. (Emergency project survival guide: First four hours, build a terminology matrix; every five pages, hit up Grammarly's technical writing mode for quality assurance.) But, word, terms like 'door operator preparation' and 'backup mechanism' were straight-up baffling, even Baidu was useless. Let me break down these two presentations:

Presentation 1:

Application scenarios Monitoring objectives Operating principles Key features of the legacy design Key advantages of the updated design Retrofit kits Promotion strategies Validation protocols Backup mechanisms Presentation 2:

Retrofit kit applications Required tooling Retrofit kit contents Door operator preparation Component replacement procedures In this technical documentation, precision is key, way more important than legal compliance, which, in turn, is more crucial than marketing BS.

What's the most head-scratching technical jargon you've dealt with? My top three: door operator torque, redundant encoders, and brake contactors – drop your war stories in the comments! For an elevator terminology database, peep the ISO 4190-5 standard.

Once you're done, use two essential tools: Grammarly's technical writing mode and Yifan document proofreading.

Finally, what's your biggest technical translation headache? ① Terminology inconsistencies ② Standard conflicts ③ Formatting issues.

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Medical Translation: Chinese to English Translation of Clinical Evaluation Report for Medical Devices

I have completed the initial phase of the project. I have finished the English translation of two clinical evaluation reports for medical devices. Given the high degree of repetition with previous documents, I utilized locked content for a significant portion of the text, resulting in a final document of approximately 1,500 words. The reports include the following sections:

I. Product Description and R&D Background

(I) Basic Information of the Applied Product

(II) Scope of Application

(III) D Background and Purpose of the Applied Product

(IV) Working Principle and/or Mechanism of Action of the Applied Product and Relevant Scientific Concepts

(V) Existing Treatment Methods, Related Products, and Clinical Application Status

(VI) Relationship between the Applied Device and Existing Treatment Methods

(VII) Expected Clinical Efficacy

(VIII) Anticipated Clinical Advantages

II. Scope of Clinical Evaluation

III. Clinical Evaluation Pathway

(I) Analysis and Evaluation through Clinical Data of Similar Medical Devices

1. Clinical Evaluation Based on Clinical Data of Equivalent Devices

2. Whether to Use Clinical Data of Comparable Devices to Support Partial Clinical Evaluation

(II) Analysis and Evaluation through Clinical Trial Data

IV. Analysis and Evaluation through Clinical Trial Data

(I) Basis for Clinical Trial Design

1. Rationality of Clinical Trial Design Type

2. Rationality of Control Group Selection

3. Rationality of Subject Population Selection

4. Rationality of Evaluation Indicators

5. Rationality of Sample Size Calculation

(II) Clinical Trial Overview

1. Clinical Trial Institution Information

2. Clinical Trial Conduct Time

3. Trial Objectives

4. Clinical Trial Process

5. Observation Indicators

6. Clinical Trial Results

(II) Clinical Trial Conclusions

1. Efficacy Analysis

2. Safety Analysis

3. Discussion and Overall Conclusions

V. Considerations and Technical Requirements When Accepting Overseas Clinical Trial Data

(I) Analysis of Differences in Technical Review Requirements

(II) Analysis of Differences in Subject Population

1. Extrapolation Principle of Overseas Clinical Trial Data

2. Race/Ethnicity Differences

3. Body Type Differences

4. Treatment Concepts

(III) Differences in Clinical Trial Conditions

(IV) Summary

VI. Conclusion

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Medical Translation: English to Chinese Translation of Protein Immunoblotting Specifications

After the Chinese New Year break, I embarked on a translation project from English to Chinese. The source material focused on a high-throughput, fully automated capillary-based protein immunoassay technology platform. Although the original text was relatively brief, approximately 700 characters, the translation process was time-intensive because of my limited familiarity with the specific product line. For example, the term "Matrix" required careful contextual analysis to determine whether it referred to a "matrix" or a "substrate." Similarly, the interpretation of "cartridges" needed clarification to ascertain if it signified a "cartridge," an "ink cartridge," or a "reagent kit." To ensure accurate comprehension of the technical nuances, I consulted numerous official websites and relevant articles on Baidu, which ultimately facilitated a clear understanding. The translation of the entire document took a full morning. The content generally covered the following key sections:

1.  A detailed description of the technical system 2.  The structural components of the instrument and its operational principles 3.  The primary advantages of this technology platform 4.  Significant differentiations compared to the previous generation of products 5.  Specific instrument specifications and parameters 6.  Relevant contact information

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Medical Translation: Standard Operating Procedures (SOPs) for Injection Testing/Sample Preparation

Last week, I wrapped up translating four Standard Operating Procedures (SOPs) from Chinese to English, clocking in at 7,700 words. This included three SOPs focused on testing and one dedicated to sample preparation. The content broadly encompasses the following elements:

1. Essential document details: title, ID, version number, effective date, pagination, issuing department, distributing department, and approvals (including drafter, reviewer, and approver).

2. Objective

3. Scope

4. Responsibilities (including QC/QA/customers)

5. Definitions, principles, and abbreviations

6. Procedures

  1. Experimental principles

  2. Key instruments and equipment

  3. Consumables and reagents

  4. Operational workflows, outlining reagent/instrument setup, solution preparation, operational methods, data processing and report generation, result analysis, system suitability, and acceptance criteria.

  5. Result reporting or determination

  6. Deviations, modifications, and exceptional occurrences

7. References or reference materials

8. Related documents

9. Attachments

10. Records

11. Version history

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Medical Translation: Chinese to English Translation of Product Manuals for Life Science Laboratory Equipment Systems

This weekend, I took on the challenge of translating a product manual for a biotech company, racking up around 3,300 words. The task revolved around transforming content from Chinese to English, focusing on the introduction of chromatography systems and various filtration products, structured as follows:

I. Company Overview

II. Team Credentials

III. Laboratory Chromatography System

1. Overview 2. Use Cases 3. Design Philosophy 4. Key Features of Each Model 5. Configuration Table, detailing model type, flow rate range, channel count, drive mode, maximum single-step volume, operational mode, flow rate precision, volume precision, chromatography type, supported solution count, batch processing capacity, operational mode, material collection, solution piping diameter, sample piping diameter, compatible chromatography column specs, working temperature and humidity range, power supply, dimensions & weight, operating pressure, UV monitor, pH monitor, conductivity monitor, temperature monitor, pressure monitor, and more.

IV. Laboratory Tangential Flow Filtration System 1. Overview 2. Key Features 3. Configuration Table, covering product number, model, equipment specs, sample mixing balance, filtration balance, main integrated pump, auxiliary pump replenishment, pressure sensors, automatic back-pressure valves, controllers, conductivity detector, pH detector, diaphragm pump peristaltic pump head, filter application suitability, treatment volume, system control mode, alarm mechanism, etc. 4. Product Benefits

V. Laboratory Microfiltration and Nanofiltration System 1. Overview 2. Configuration Table, including suitable application filters, processing volume, system control mode, alarm mechanism, gas inlet and outlet balance parameters, tank material, maximum inlet pressure, pressure sensor specs, piping interface, working temperature and humidity range, dimensions & weight, and power supply, etc.

VI. Multifunctional Laboratory Product

Pressure Detector Set, featuring an introduction, key features, and a configuration table (pressure monitoring range, readability, accuracy, pressure sensor material, connection, control mode, UV module specs, pH module specs, conductivity module specs, temperature module specs, communication interfaces, display, working temperature and humidity range, dimensions & weight, etc.)

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Legal translation: English to Chinese translation of the Letter of Engagement and the annexed Standard Terms of Engagement

Last weekend, I took on the gig of translating a legal service engagement letter from an international law firm to a local pharmaceutical company, switching it up from English to Chinese. This document is known as a "Business Engagement Letter," which is basically your standard contract for legal services from law firms. It’s a written deal that both the trustee and the client sign off on, confirming the delegation of a specific business, laying out the legal relationship between the parties, detailing the purpose of the engagement, the scope of services, fee structures, and the rights and obligations of both sides. This "Business Engagement Letter" and its sidekick, the "Standard Business Engagement Terms," clock in at over 7,000 words. The engagement letter includes:

(1) Client Information

(2) Employee Information

(3) Scope of Services

(4) Payment

(5) Liability

(6) Duration of Services

(7) Next Steps

The attached "Standard Business Engagement Terms" cover:

1. The contract between both parties

2. Scope of matters and suggested benefits

3. Legal team

4. Authorization

5. Personnel allocation

6. Fee arrangements and client funds

6.1 Party A's fees

6.2 Cost estimates

6.3 Maximum or fixed fee quotes

6.4 Custody of client funds

6.5 Invoicing

6.6 Payment terms

6.7 Advance payments

7. Obligations of Party B

8. Right of complaint for Party B

9. Confidentiality

10. Use of email or other communications

11. Document retention and disposal

12. Copyright

13. Data protection

14. Limitation of liability

14.1 Exemption clauses

14.2 No liability to third parties

14.3 Maximum liability and proportional liability

14.4 Personal liability of partners

14.5 Exceptions to liability limitations

15. Professional rules and primary regulations

15.1 Legal requirements

15.2 Bar association

15.3 Professional indemnity insurance

15.4 Anti-money laundering/anti-terrorist financing obligations

16. Termination

17. Third-party rights

18. Severability

19. Governing law and jurisdiction

20. Definitions and interpretations of terms.

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Medical translation: English translation referencing and comparing to similar and/or previous generation medical devices.

I landed a last-minute gig over the weekend translating a technical document from English to Chinese, diving into a piece that compares the latest medical devices with their older counterparts, totaling around 1500 words. The content generally covers the following:

1. Product name

2. Model number

3. Registrant's name

4. A detailed side-by-side comparison of new and old devices, looking at system components, power supply, battery, operating modes, user interface, data download, display screen, functions, structure, materials, operational parameters, working modes, duration and method of human contact, intended use, hardware, software, and more.

5. Breakdown of differences:

5.1 Software features of the product, including software model/version, user data input, display content, etc.

5.2 Hardware features of the product

5.3 Operating modes of the product

5.4 Performance metrics of the product

5.5 How the product operates

5.6 Details on component materials and composition

5.7 Specifications and diagrams of components

6. Conclusion

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English to Chinese Translation of Medical Device Software CPU Descriptions

This here gives you the lowdown on two documents that deal with translating medical device software (CPU) descriptions from English to Chinese, and we're talking over 3000 words in total. The detailed content covers:

1.0 Purpose   2.0 Scope   3.0 Abbreviations/Definitions   4.0 References   5.0 Revision History   6.0 Overview   7.0 Development Framework   8.0 System Architecture   8.1 Main Loop   8.2 Timer Interface   8.3 Serial Communication Interface   8.4 Pressure Sensor Interface   8.5 Temperature Data Management   8.6 Support Programs  

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Medical translation: Chinese to English translation of a site audit report prior to the transfer of a preparation to a new site

Last year, I had the chance to translate various audit reports, but my initial experience with a medical audit report proved to be quite challenging. When I first laid eyes on the document, it felt daunting, as it contained over 4,400 words. I thought I could finish it in less than two days, but it ended up taking me an additional half day. I probably spent around two hours just trying to grasp the title! [laughing and crying emoji] The key elements of this document include:

1. The objective of the quality audit 2. Participants involved 3. Basis for the audit 4. Review content (covering institutions and personnel, facilities and equipment, materials and products, confirmations and verifications, document management, production management, quality control and quality assurance, etc.) 5. Audit findings   5.1 Certification of the quality system   5.2 Production history and capacity for clinical trial medications   5.3 Current status of audited items   5.4 Structure and operation of the quality management system   5.5 Product co-line   5.6 Process for product introduction/site changes   5.7 Quality control and quality assurance measures   5.8 Facilities and equipment 6. Defect status table (including categories, defect levels, risk descriptions, references, recommendations, etc.) 7. Conclusions from the inspection

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English to Chinese Translation of Software Requirements Specification

A document from a foreign medical tech company called "Software Requirements Specification," which lays out the usage needs for renal perfusion software, about 3000 words long, translated from English to Chinese, typically covers the following sections:1. Approval2. Scope2.1 Software Identification2.2 System Overview2.3 Document Overview2.4 Baseline3. Reference Documents4. Requirements4.1 Requirements Overview4.1.1 Objectives4.1.2 Interfaces4.2 Functional Requirements4.2.1 Control Panel4.2.2 Display Panel4.2.3 Battery Panel4.3 Software Quality Factors Requirements4.3.1 Functionality Requirements4.3.2 Usability Requirements4.3.3 Reliability Requirements4.3.4 Information Security Requirements4.3.5 Maintainability Requirements5. Revision History

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Medical Translation: Chinese to English Translation of Customer Complaint Management Regulations

A certain medical technology firm has a document called "Customer Complaint Management Regulations." This document is moderately lengthy, around 2000 words, and it needs a precise translation from Chinese to English. I dedicated almost an entire day to get it done, and the main sections cover the following:

1. Purpose   2. Scope of Application   3. Responsibilities (including the Marketing and Sales Department, Quality Regulations Department, various departments, and management representatives, etc.)   4. Definitions   5. Flowchart   6. Procedures   6.1 Feedback Reception and Recording   6.2 Determination of Feedback Information   6.3 Investigation of Complaints   6.4 Reporting to Regulatory Authorities   6.5 Analysis of Complaint Causes   6.6 Handling of Complaints   6.7 Statistics and Analysis of Complaint Information   7. Related Documents   8. Records   9. Revision History

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Medical Translation: Chinese to English for Product Labelling and Traceability Control Procedures

I completed a 2200-word draft of the "Product Identification and Traceability Control Procedure," translating it from Chinese to English over the course of one night and the following morning. The document covers the following topics:

1. Purpose

2. Scope of Application

3. Responsibilities (including Quality Management, Production, Purchasing, and Warehouse Management)

4. Terms and Definitions

5. Management Requirements

5.1 Basis and Contracted Production

5.2 Identification Methods for Materials, Intermediate Products, and Finished Goods

5.3 Identification Methods for Production Areas and Status

5.4 Identification Methods for Equipment Status

5.5 Identification of Returned (Recalled) Products

5.6 Handling of Unlabeled or Poorly Labeled Products

5.7 Product Traceability Requirements

5.8 Methods for Product Traceability

6. Related Documents

7. Related Records

8. Cited Standards and Reference Documents

9. Appendix

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A translation of a "Production Process Control Procedure" document, roughly 1500 words, from Chinese to English was wrapped up at the start of the month. The report dives into the following sections:

1. Purpose

2. Scope of Application

3. Responsibilities (covering the Production Department, Quality Management Department, Engineering Department, and Warehouse Management Department)

4. Terminology and Definitions

5. Management Requirements

5.1 Control of Critical Processes and Special Procedures

5.2 Control of Production Process Environment

5.3 Monitoring of Production Processes

5.4 Non-Conforming Products

5.5 Corrective and Preventive Actions

5.6 Management of Records

5.7 Product Protection6. Related Documents

6. Related Records

7. Referenced Standards and Reference Documents

8. Appendix