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Medical Device Intelligence 

Classification, Competitive Analysis and Advise

Classification

As simple as it may sound, the risk classification / demarcation of your device can be surprisingly difficult. Our intuitive tool helps you find out if your device is Class I (m|s|r), Class IIa, Class IIb, or Class III.

We also offer an extensive report explaining the  consequences of the classification:

  • Involvement of Notified Bodies

  • Conformity Assessment Procedures

  • Technical Documentation

  • Post-Market Surveillance

  • Clinical Evaluation

  • Clinical Evidence

  • Scrutiny Procedure​​​​

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Competitive Analysis

Get reliable insights with our competitive analysis services for medical devices. Our team offers detailed evaluations of market trends, competitor strategies, and regulatory changes, tailored to your needs. Whether you're introducing a new product, refining your market approach, or creating a PMS report, our analysis provide the essential information for your needs.

Advise

Optimize your operations and drive innovation with our comprehensive services. We streamline processes, improve efficiency, and reduce costs in areas like supply chain management and quality control. Collaborate with us for R&D innovation, hardware and software development, and regulatory compliance. Our expertise ensures smooth navigation through FDA and CE marking requirements. Additionally, we offer data collection tools and analytics for clinical investigations and conduct post-market studies to maintain product excellence. Partner with us for a holistic approach to operational excellence and R&D innovation.

Strategic Partnership

Oslo - Reykjavik -

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