Regvo

EU MDR FDA

Regvo is a UK regulatory practice led by founder and regulatory affairs specialist Natalia Szychulska. It supports medical device startups and growing companies with classification, regulatory strategy, technical documentation and post-market compliance. Its stated coverage includes EU MDR, UKCA and FDA pathways, with experience in software as a medical device and digital health. Clients work directly with the founder, who can involve specialist collaborators when a project requires them.

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How is medical device regulation developed and how can its usability be improved for start-ups?

Anonymous · 1 comment

about 1 year ago

I am interested in understanding how medical device regulation, specifically the MDR, is developed and what could be done to improve its usability, especially for small start-ups. From my experience a

Accepted 3 answers

Regulation like the MDR is developed at the EU level as part of the "new legislative framework" for product safety. The process involves EU institutio

How can the usability of the MDR and related standards be improved for startups?

Anonymous · 1 comment

6 months ago

One user described difficulties in applying the Medical Device Regulation (MDR) and related standards, especially as a startup. The user finds the regulations and standards difficult to read and under

Accepted 4 answers

Great question! I think improving the usability of the MDR and related standards is a big challenge, especially for startups. The MDR is law and ISO s

PRRC Appointment Letter

Sören Hornof

updated over 2 years ago