With three decades of expertise, MEDIcept, headquartered in Boston, MA, specializes in medical devices, IVD devices, combination products, and biotechnology compliance consulting. We help companies of all sizes navigate the complexities of FDA and global regulations to successfully bring their products to market. Many businesses underestimate the challenges of regulatory compliance, but our expert medical regulatory consulting ensures a smoother path to regulatory clearance.
Support for Regulatory Strategy Development
Whether you're a start-up or an established enterprise, a well-defined regulatory strategy is critical. MEDIcept’s medical regulatory consulting services for medical device companies include:
- Global Regulatory Strategy Development
- Regulatory Submissions (FDA, EU MDR, EU IVDR, and more)
- Premarket Approval Submissions
- Adverse Event Reporting
- Regulatory Due Diligence
- Labeling, Website, and Marketing Review
- De Novo Classification Requests
- And More!
Our comprehensive knowledge spans all regulatory pathways, enabling medical device manufacturers and importers to efficiently enter the U.S. market. From serving as a U.S. Agent to securing FDA feedback, MEDIcept provides critical support at every step.
Consulting for Global Market Expansion
For medical device companies operating in or expanding into international markets, MEDIcept offers invaluable medical regulatory consulting to medical device companies for navigating complex regulations and regulatory agencies like the EU MDR, EU IVDR, UK MHRA, Australia TGA, Brazil ANVISA, and Canada MDL and MDEL. As European regulations grow increasingly intricate, having an experienced partner is essential.
If your organization needs expert medical regulatory consulting, MEDIcept can develop a robust strategy to support your regulatory goals. Our team of former FDA, Notified Body, and industry professionals will collaborate with you to create a plan that aligns with your business objectives. Contact us today to learn how we can streamline your regulatory journey and position your medical device company for success.