Medical devices development is a complex process and it requires a lot of efforts from cross-functional teams to develop the device from conception to submission worthy condition. Amongst all, Regulatory strategy plays a pivotal role in deciding the fate of the medical device in development stage. A small modification in an early design stage may change the risk-based classification of the medical devices to a greater degree. Incorporating these changes at a later stage may cost huge capital to the manufacturer as the Regulatory expenditure and timelines exponentially increase with the change in classification. Hence, a careful consideration on implementing Regulatory strategy and approach in-time will be beneficial for the companies.
Freyr’s Regulatory experts assist the medical device manufacturers in chalking out clear Regulatory submission pathway. In addition to that, manufacturers looking for global expansion also need a proper Regulatory strategy to navigate through complex markets like APAC, MENA, and LATAM. Freyr, with presence in 120+ countries, assists organizations in obtaining necessary Regulatory approvals.
- Advice on Regulatory submission pathway
- Device classification
- Pre-submission/scientific advice meetings
- Advisory boards
- Device registration requirements
- Assistance with notified body selection
- End-to-end medical device Regulatory consultation
- Qualified team of experts with hands-on experience across all categories of medical devices
- Support for region-specific Regulatory complexities
- Extensive partner network across the globe
- Strong relationship with different Health Authorities (HAs)
- Structured approach to ensure quick market access