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Tools for ISO 13485:2016 transition

Update your certificate to 2016 revision with ease


Get free expert help with your ISO 13485:2016 transition
At 13485Academy, we are happy to offer a consultation with our industry-leading professionals – free of charge. No catch, no strings attached, and no unpleasant surprises – just expert advice to help your company.
Strahinja Stojanovic
Lead ISO 13485 Expert,
Strahinja Stojanovic is an expert in Quality Management and ISO 13485. His wealth of experience has helped companies just like yours in their ISO 13485 implementation efforts.

He participated in implementation of these standards in more than 100 SMEs, through creation of documentation and performing in-house trainings for maintaining management system, internal audit and management review.

Schedule a time to chat with Strahinja Stojanovic, or just send him a question. Please note that the free consultation will be provided in English.

Twelve-step transition process from ISO 13485:2003 to 2016 revision

This white paper is intended for companies that have implemented the ISO 13485:2003 revision, and are planning to transition to the 2016 revision. The paper describes the suggested steps in the process.

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Checklist of Mandatory Documentation Required by ISO 13485:2016

This white paper lists all the mandatory documents and records, and also briefly describes how to structure each document. It gives a perfect overview of your ISO 13485:2016 QMS.

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ISO 13485:2003 vs. 2016 Conversion Tool

This free tool will help you to convert ISO 13485:2003 clauses to the new ISO 13485:2016 clauses. Just select the number of your current clause and find out what kind of changes you need to perform.


The record formats given for each and every process had really helped us. Prior to this we didnt know what are the data in a specific record needs to be maintained. It is good and we have faced the external audit with confidence.
Thiyagarajan Murugesan
Associate Director - Internal Control and Compliance
The toolkit has helped clarify the requirements of the standard, and really helped speed up the process of creating the documents.
Darren Pulman
Data Services Manager
I had no real idea of where to start, how to organize the project, what the actual requirements and decisions to make were. The toolkit was invaluable to me.
John Salvatore
CISO & Lead Software Engineer
The templates sped up our documentation process and the webinars helped illuminate critical items.
Ted Smith
Vice President of Engineering, Chief Information Officer
Rogue Wave Software



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