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Navigate quality management essentials in our illustrated guide, now as an ebook!

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FREE ISO 13485:2016 blog feature image

Free ISO 13485:2016 standard and where to download the PDF

clinical investigation and clinical evaluation of medical devices

Clinical investigation and clinical evaluation of medical devices

scope-and-purpose

The scope and purpose of SOPs and controlling documents

General safety requirements for electrical medical devices feature image

General safety requirements for electrical medical devices

February 22, 2021 No Comments

How to define IEC 60601 test plans and protocols for medical devices feature image

How to define IEC 60601 test plans and protocols for medical devices

February 17, 2021 No Comments

Design Control for medical devices - What is it and why you should do it feature image

Design control for medical devices – what is it and why you should do it

January 26, 2021 No Comments

What is a medical device? feature image

What is a medical device?

January 25, 2021 No Comments

How to perform medical device design review feature image

How to perform a medical device design review

January 21, 2021 No Comments

How to identify and manage critical components feature image

How to identify and manage critical components

January 15, 2021 No Comments

Developing an insulation diagram for electrical medical devices feature image

Developing an insulation diagram for electrical medical devices

December 8, 2020 No Comments

Proactive safety by Design with Medical Device Risk Management feature image

How to integrate proactive safety by design with medical device risk management

November 2, 2020 No Comments

Risk management for medical device and ISO 14971:2019 infographic feature image

Risk management for medical device and ISO 14971:2019 infographic

August 3, 2020 No Comments

Where to buy and download ISO 14971:2019 standard as PDF feature image

Where to buy and download the ISO 14971:2019 standard as PDF

July 13, 2020 No Comments

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Would you like to learn more about
risk management or design control?

Take a look at our online Risk Management course on ISO 14971:2019 and online Design Control for Medical Devices course.
These courses are taken by both competent authorities, notified bodies and medical device manufacturers and distributors.