Global Medical Device Regulatory Affairs and
Regulatory Compliance Consulting and Contracting
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The new EU Medical Device Regulation (MDR 2017/745) represents a seismic change in how medical devices are regulated in the EU. Complying with the new regulation presents a whole new set of challenges for medical device manufacturers, and it is key to understand those changes and develop a sound transition strategy. We can help with this regulation and requirements
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Accelerating developments in Global Cybersecurity requirements is another example of the complex regulatory environment that must be navigated. Medical device manufacturers must be current with regulatory affairs compliance requirements to assure security needs are met. We can assist with these regulations and requirements.
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Sound regulatory strategies and proper filings can control costs, improve quality, and achieve faster market clearance. We can help your team remain up-to-date with regulations and requirements
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Global Services in Regulatory Affairs, Quality Systems, and Clinical Affairs
- US/FDA
- EU/MDR
- Emerging Markets
- Cybersecurity
- Regulatory Strategies
- Design Control
- QSR 820, ISO 13485, and EN/ISO/ASTM/IEC Standards
- Global Device Submissions/Supplements and Authorizations