MethodSense

FDA EU MDR Cybersecurity

MethodSense is a Morrisville, North Carolina regulatory and quality consulting firm for medical device companies. Its team develops regulatory roadmaps and supports FDA 510(k), De Novo, PMA and Q-Submission work, as well as EU MDR documentation and CE marking. Specialty services cover SaMD, AI/ML validation, predetermined change-control plans, software lifecycle records, cybersecurity controls, threat models and software bills of materials.

Learn more

No image yet.

Notified body

DNV Product Assurance

updated about 2 years ago

What is my company's role under MDR when incorporating a CE-marked software medical device from another manufacturer into our non-medical app?

Anonymous · 2 comments

8 months ago

I am planning to incorporate a CE-marked software solution (manufactured by another company) into our app, which itself is not a medical device. The software will be made directly available to our use

Accepted 2 answers

We were in a similar situation and the competent authorities defined our role as a distributor. If you are making the CE-marked software medical devic

10:40

Medizinprodukteberater Course: Requirements, Tasks, Responsibilities

Dr. Oliver Eidel

30 views · 7 months ago