World-Class Regulatory Services and Strategies
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.
- 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
Submissions, Notified Bodies and Regulatory Authorities
We take care of device approval submission, maintain efficient contact with Notified Bodies and relevant Regulatory Authorities.
Post Market Surveillance
We take care of vigilance, post market clinical follow-up and update of the technical file.
Global Regulatory Community
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.
Contact us to find out more about Regulatory Affairs