Regulatory Affairs and Strategic Planning

Getting your medical device to market

Navigating the intricate terrain of regulatory compliance demands current knowledge, substantial experience, and well-established connections. Our strategic consulting team serves as your compass, steering you along the most efficient and optimal path toward achieving CE-mark, device registration, and approvals beyond the EU. We also provide essential support in establishing and implementing post-market surveillance measures.

In the midst of the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), understanding the implications on regulatory requirements and timelines is paramount. Our team is readily available to guide you through this transitional phase.

Efficient Submissions, Collaborative Notified Bodies, and Regulatory Authorities

We handle the submission of device approvals and maintain effective communication with Notified Bodies and pertinent Regulatory Authorities.

Comprehensive Post-Market Surveillance
Our expertise extends to vigilance, post-market clinical follow-up, and the continuous updating of the technical file.

Global Regulatory Expertise
Our consulting team boasts an extensive understanding of regulatory systems worldwide. Combined with our knowledge of Notified Bodies and Regulatory Authorities, we streamline the process of device registration and approvals, ensuring a swift and efficient outcome.

Regulatory Affairs

Finding your way through the regulatory landscape can be difficult as it requires up-to-date knowledge, experience and contacts. Our strategic consulting team guides you along the most efficient and optimal strategic path to CE-mark, device registration and/or approval outside EU and support in building up and use post market surveillance.

As the industry moves from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) it is important to understand the implications on the regulatory requirements and timescales. Our team are available to support you through this transition.

We take care of device approval submission, maintain efficient contact with Notified Bodies and relevant Regulatory Authorities.

We take care of vigilance, post market clinical follow-up and update of the technical file.

Our consulting team has an in-depth knowledge of regulatory systems world-wide. Combined with our knowledge of the notified bodies and regulatory authorities, this means that we can help you with device registration and/or approvals quickly and efficiently.

  • Classification and Regulatory Strategy with reference to the Intended Use and Commercial Markets
  • MDR Gap analysis
  • Project Definition
  • Risk Management
  • Build up Design History File and Summary of Technical Documentation (STED) with all aspects of the Technical File
  • Support in selection and handling of materials and in preparation of Biological and Clinical evaluations based on literature studies
Will we see you in London?

30% Off

..when you use the code ‘discount30%’ at registration.