seleon

EU MDR IVDR Clinical Evaluation Cybersecurity

seleon is a medical technology service company headquartered in Heilbronn, Germany. It combines product development, regulatory consulting and manufacturing support for active and non-active medical devices, IVDs and combination products. Its consulting work covers regulatory affairs, clinical affairs, technical documentation and medical-device software topics, including cybersecurity, supporting manufacturers from early concepts through market readiness and post-market lifecycle work.

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Questionnaire "Cybersecurity for Medical Devices - Technical Documentation"

Dr. Oliver Eidel

updated almost 2 years ago

List of Medical Device Consultants

Sven Piechottka

updated over 2 years ago

Recommendations for EU Notified Bodies for CE and MDR applications outside Germany

Anonymous · 1 comment

6 months ago

Our company is developing a medical device software and is seeking recommendations for Notified Bodies in the EU, outside of Germany, where we can apply for CE marking and MDR certification within thi

Accepted 2 answers

A few months ago, Kiwa Dare in The Netherlands still had capacity to accept or at least discuss new customers, and they handle medical device software