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Career in medical devices space

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Guest user Created:   Oct 15, 2021 Last commented:   Oct 18, 2021

Career in medical devices space

For someone interested in entering the medical devices space, can you advise on an approach to this side of the industry?
What certifications are needed? What career ladder is there? What paths are possible? Can this be self-taught? Can you share your experience?

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Kristina Zvonar Brkić Oct 18, 2021

To be in the medical device field, first, you need to have some medical background. For example: completed medical school, work experience in a hospital or other clinical institution, work experience in a medical device factory. In my opinion, without understanding what are the most important elements for medical device safety and performance is not possible to be in this field. 

The benefit is if you have experience in regulatory business, to know how to read and understand different regulatory requirements, and so on. If you are on the market of EU, then knowledge of MDR is mandatory, and if you are from the US market then you need to know the FDA rules for medical device certification. 

There are websites that offer some certifications for consultants, but even that certification is no guarantee that you fully understand the regulatory requirements. So without a lot of self-study of necessary regulations, there is no success in this business. 

The only thing to keep in mind is that there are medical products and a syringe for giving injections, but also an artificial heart. So there is no consultant who has experience in all types of medical products. Some requirements are universal, but again each product has its own specifics that the consultant must take into account. So the mutual communication of the consultant is also important.

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Oct 15, 2021

Oct 18, 2021