Regulatory Affairs
Finding the right regulatory strategy and troubleshooting an existing strategy is something we take very seriously. It is essential to build a strategy integrated with the business strategy and eliminate as much uncertainty as possible. Through an extensive network with regulators and notified bodies, predictability is what we are striving to achieve for our clients.
Our team of regulatory and quality experts adopt the most cost-effective approach in compliance with local regulations to get your medical device registered rapidly and efficiently. We also offer a range of industry-leading services designed to optimize the positioning of your product.
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Global
- Worldwide regulatory and clinical strategy
- Define pre-clinical strategy and implement
- Support with preparing technical file
- Risk Assessment process
- Market access regulatory processes worldwide, contact us for inquiries on your target countries
Europe
- Troubleshoot matters with notified bodies or regulators
- Notified body selection
- Authorized Representative Services under MDR/IVDR (IVDD and MDD till switch to MDR/IVDR)
- MDCG expert panel meetings (as soon as operational)
- CE-mark process support
- Orphan Medical Device Designation Application
USA
- 510K and PMA submissions
- IDE submissions and pre-sub meetings where needed
- Breakthrough device program applications
China
- NMPA green channel process
- NMPA submissions and related meetings
- Prepare and manage pre-clinical type testing
- Legal representative
