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Regulatory Strategy and Approach



Medical Devices development is a complex process and it requires a lot of effort 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 state of the Medical Device in the 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 Medical Device Regulatory strategy and approach in-time will be beneficial for the companies.

Freyr’s Medical Device Regulatory Strategy Consulting Experts assist the device manufacturers in chalking out clear Regulatory submission pathway. In addition to that, manufacturers looking for global expansion also need a proper medical device 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.  

Freyr Expertise and Advantages

Freyr Expertise

  • Regulatory Strategy Consulting services
  • Advice on Regulatory submission pathway
  • Device Classification
  • Pre-submission/scientific advice meetings
  •  Advisory boards
  • Medical Device Regulatory Consulting
  • Device registration requirements
  • Regulatory Affairs Strategy
  • Assistance with Notified Body selection

Freyr Advantages

  • Cost-effective
  • 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