Integration of IEC62304 in the Quality Management System under ISO13485

Highlights, steps and challenges when implementing IEC62304 and IEC 82304 in the general quality management system for medical device software.

View of the Speaker

A presentation by Jonathan Boel, Senior Project Manager & Digital Health Core Team Lead at QbD.

Question 1: What drives you?
Help and assist customers in the quality management implementation or software validation approach for medical device products. Especially the more complex products, with AI/ML components, adherence to a jungle of standards, etcetera.

Question 2: Why should the delegate attend your session?
Pragmatic view and approach to common questions and issues.

Question 3: What emerging technologies / trends do you see as having the greatest potential in the short and long run?
There are many already here and many are still coming, but AI and ML are definitely key at the moment.

Question 4: What kind of impact do you expect them to have?
More accurate results and results, which could not be processed before.

Question 5: What are the barriers that might stand in the way?
Not necessarily stand in the way, but slowing down is definitely regulation. On the other hand, need to be there to ensure alignment and ensure safety for the patient and end-users.

About Jonathan Boel
Consultant for more than 10 years within the pharmaceutical industry in roles as Computer System Validation, Data integrity lead Project Manager & Quality Assurance.

About QbD
Beginning of 2022, the Digital Health Core Team was initiated at QbD. Its purpose is there to support all of our clients across different industries with their questions on #digitalhealth.

Jonathan Boel is speaker at the 2022 edition of the Health Tech Event.

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