The video provided below shows you exactly what you will receive when you purchase our translation procedure (SYS-052) and associated forms.
The video above explains what you get when you purchase this translation procedure and how to modify the procedure so it is customized for your company’s quality system. This procedure was written by Matthew Walker. The procedure includes requirements for qualifying a quality translation service for translation of your medical device labeling and for managing the translation process.
Originally, SYS-030 was our labeling and translation procedure. However, we decided to improve and expand our translation procedure to include the requirements for ISO 17100, Quality Translation Services. A supplier questionnaire and a regulatory checklist are included with the translation procedure. These documents are updated for ISO 13485:2016 and the new European Regulations (i.e. Regulation EU 2017/745, the MDR and Regulation EU 2017/746, the IVDR). The following is a list of included documents:
- SYS-052 A, Translation Procedure
- FRM-054 A, TSP Supplier Questionnaire
- FRM-055 A, Regulatory Document Translation Checklist
SYS-052, Translation Procedure; This training includes our procedure and forms for translation of labeling and IFUs.
If you have specific questions about device labeling, or MDR compliance, please use our calendly app to schedule a call with a member from our team.
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download. To view all available procedures click here.
About the Author
Matthew came to us with a regulatory background that focused on OSHA and NFPA regulations when he was a Firefighter/EMT. Since we kidnapped him from his other career, he now works in Medical Device Quality Management Systems, Technical/Medical Writing, and is a Lead Auditor. Matthew has updated all of our procedures for He is currently a student in Champlain College’s Cybersecurity and Digital Forensics program, and we are proud to say that he is also a member of both the Golden Keys and Phi Theta Kappa Honor Societies! Matthew participates as a member of our audit team and has a passion for risk management and human factors engineering. Always the mad scientist, Matthew pairs his professional life in regulatory affairs with hobbies in the culinary arts as he also holds a Butchers/Meat Cutters certificate from Vermont Technical College.
Connect on Linkedin: http://www.linkedin.com/in/matthew-walker-214718101/