NQSC

EU MDR IVDR FDA Clinical Evaluation

NQSC is an India-based compliance consultancy serving medical-device manufacturers, IVD companies, importers and exporters. Its device work includes CDSCO licensing, ISO 13485, technical files and audit readiness. For international market access, it supports EU MDR and IVDR documentation, FDA documentation, clinical evaluation reports, risk files, quality systems and post-approval maintenance.

Learn more

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

12:37

Clinical Evaluation: The Clinical Evaluation Report (CER)

Dr. Oliver Eidel

59 views · 8 months ago