IMed Consultancy

EU MDR IVDR

IMed Consultancy is a UK medical device regulatory firm established in 2012 and based in Oxfordshire. Its consultants work with medical devices, diagnostics, IVDs and software products from early development through global market access. Services include regulatory strategy, EU MDR and IVDR compliance, quality-system leadership, remediation, post-market surveillance and authorized representation through related UK and Irish entities. The team supports startups, established manufacturers and global portfolios.

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Is CE marking required for internally used EEG analysis software provided as a service to hospitals?

Anonymous · 2 comments

8 months ago

We are a startup providing EEG analysis services to psychiatric hospitals using software developed for our own internal use. We are ISO 13485 certified and initially planned to CE mark the software as

Accepted 2 answers

This is a really interesting situation. Under the MDR (and IVDR), the main factor is whether the software is considered to have a medical purpose and

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

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Medizinprodukteberater Course: Requirements, Tasks, Responsibilities

Dr. Oliver Eidel

30 views · 7 months ago