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Regulatory Intelligence

Overview

Overview

The Medical Device industry is one of the largest industries in the healthcare sector, with significant growth in the last few years. The industry is undergoing continuous transformation to comply with the ever-changing regulations introduced by global Regulatory Authorities, to ensure strict controls over device performance and safety. In such a scenario, having a better understanding of the Regulatory environment and updated Regulatory information, to design and implement good strategy can result in reduced costs, reduced time-to-market and maximum compliance.

The Medical Device Regulatory Intelligence Framework comprises of up-to-date global regulations, HA standings in multiple Regulatory topics for increased market specific Regulatory insights. The Medical Device Regulatory Intelligence is a multi-dimensional activity and includes monitoring of Regulatory environment, Procedural and competitor intelligence.

Freyr, with expertise in global Medical Device Regulatory landscapes, brings forth the best of information on Health Authorities regulations and regional market scenarios. Freyr caters comprehensive Medical Device Regulatory Intelligence services as, ad-hoc RI reports, periodic global Regulatory update reports, newsletters corresponding to organizational needs, based on the region and device type.

Freyr Expertise and Advantages
Expertise

Freyr Expertise

  • Comprehensive Regulatory Intelligence report on all the Regulatory requirements including market trends and forecast for a country
  • Country-wise updates for Medical Devices covering the Regulatory news and their anticipated impact and recommendations
  • Timely alert to client in case any prompt action is required 
  • Procedural Intelligence
  • Weekly, Monthly, bimonthly and Quarterly Reports
  • Regulatory Intelligence Newsletters
  • Regulatory Data Analysis Reports
  • Regulatory trend reports
  • Complexity Scoring Reports
  • Country Reports
  • Freyr Impact tool for RI
Advantages

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)
  • Ad hoc request support with quick turn around time