Donawa Lifescience Consulting

EU MDR FDA Clinical Evaluation

Donawa Lifescience Consulting is a medical device and IVD regulatory consultancy and contract research organisation headquartered in Rome. It supports companies from feasibility through commercialisation with European CE-marking and US FDA regulatory requirements, quality management systems and clinical research. The firm works with devices, diagnostics and combination products, combining regulatory and quality consulting with clinical investigation planning and operational support.

Learn more

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

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