SpringRA

FDA EU MDR Clinical Evaluation

SpringRA is a Toronto-based medical device regulatory and quality consultancy. Its pre-market services include FDA Q-Submissions, 510(k) and De Novo applications, Health Canada licensing and EU MDR technical documentation. The firm also supports quality-system development, software and AI documentation, clinical evaluation reports, post-market surveillance and responses to notified-body findings across device, diagnostic and digital-health projects.

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Free MDR Templates

Dr. Oliver Eidel

103 views · over 2 years ago

SaMD : Is the frontend part of the medicla device under EU MDR ?

Anonymous

8 months ago

In a CE-marked SaMD under EU MDR, only the backend of our software performs the medical function (clinical data processing, rule evaluation, alert generation). The frontend performs no medical logic a

No answers yet

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