SIFo Medical

EU MDR FDA

SIFo Medical is an Austrian medical device consultancy founded by Simon Föger and based in Telfs. It provides hands-on support for quality systems, design control, risk management, validation, supplier quality and technical documentation. Its stated documentation work covers EU MDR, FDA and ISO 13485 requirements. SIFo works with startups, small and medium-sized manufacturers and larger companies, using a network of medical technology quality specialists.

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Getting Started

EU MDR: Step-By-Step Guide To Becoming Compliant

Updated 9 months ago

Dr. Oliver Eidel

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 ISO 13485 certification required before CE marking for software medical devices in the EU and Switzerland?

Anonymous · 1 comment

6 months ago

We want to certify our software as a medical device in the EU and Switzerland. I have two questions: • Is it necessary to first obtain ISO 13485 certification before applying for CE marking? What are

Accepted 4 answers

For your first question: MDR requires manufacturers to establish a QMS (Quality Management System), as stated in Article 10 MDR. For class IIa devices