ISO 13485:2016 – 5 Frequent Errors and How to Address
- January 24, 2024
- Posted by: MSECB Marketing
- Categories: Experts Talk, Quality, Environment, Health and Safety & Sustainability
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Explore ISO 13485:2016 challenges through the expertise of Danny Kroo. Learn about common misinterpretations for improved quality management.
The rising importance of Quality in the Medical Device Industry
- November 23, 2021
- Posted by: Jasemina Bekteshi
- Categories: Experts Talk, Quality, Environment, Health and Safety & Sustainability
ISO 13485:2016 is the global standard for Quality Management Systems in the medical device industry, developed by ISO in its third edition.
COVID-19 increases the need for new medical devices
- November 23, 2021
- Posted by: Jasemina Bekteshi
- Categories: Experts Talk, Quality, Environment, Health and Safety & Sustainability
This article overviews the challenges in designing and developing medical devices per legal, regulatory, and ISO management system standards.
ISO 13485 (Medical Devices QMS) – Q&A Session
- November 22, 2021
- Posted by: Jasemina Bekteshi
- Categories: Experts Talk, Quality, Environment, Health and Safety & Sustainability
This session answers FAQs about ISO 13485:2016, designed for organizations involved in medical device design, production, and servicing.
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