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
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 Walker – QMS, Risk Management, Usability | Human Factors Engineering, Cybersecurity & DFIR
Matthew brings a unique background as a former Firefighter/EMT and Rope Rescue Tech with expereince in OSHA and NFPA regulations. For the better part of a decade, he has worked as a Technical/Medical Writer and Lead Auditor. He holds degrees in Fire Science and Computer Forensics and Digital Investigations, graduating Summa Cum Laude from Champlain College. Matthew is also an active member of several academic honor societies including Omicron Sigma Sigma’s Order of the Sword and Shield. His professional focus includes Human Factors Engineering, Risk Management, and Cybersecurity with a special interest in applying Digital Forensics and Incident Response (DFIR) practices to medical technology. He combines regulatory expertise with technical insige to strengthen both product safety and oranizational resiliance. He can be reached by email. You can also follow him on LinkedIn or YouTube.