Medical Device Regulatory Services
Leverage our proven regulatory affairs expertise to expand the market for your medical devices—and fuel your growth.
Navigating regulatory affairs for medical devices can be a daunting challenge—especially without the assistance of an established expert. Having to coordinate with myriad regulatory agencies—each with its own requirements, regulations, and guidance—can make approval a lengthy process.
Working with a team that has traveled this road before can significantly improve your chances of success. That’s why Mapi offers medical device companies the following services to expedite the regulatory process:
- Pre-market notification — 510(k)
- Pre-market approval — PMA
- Investigational Device Exemption — IDE (for clinical studies)
- Combination product (drug/device) submissions
- Establishment registration and device listing
- US Agent
- Strategy, agency meetings
- Medical device license applications (Class II, III, IV)
- Investigational Testing Authorizations (for clinical studies)
- Combination product (drug/ device) submissions
- Medical Device Establishment Licenses
- Strategy, agency meetings
- Technical File, Design Dossier preparation
- Clinical Evaluations
- CE Mark facilitation
- Quality systems to meet ISO 13485, US QS Reg, and regulations for US, Canada, and EU; internal and supplier audits
With more than 120 regulatory consultants and related staff, Mapi has the collective experience and global scope to handle a wide range of projects. Work with our team to plan and execute your optimal path to approval across multiple jurisdictions.
Our client, a mid-size manufacturer of orthopedic implants and instruments based in Europe, determined that its primary growth strategy involved expanding sales to North American markets. The manufacturer held an ISO 13485 certificate, but its devices were CEmarked for Europe only.
Furthermore, the client’s quality system did not meet either US or Canadian requirements, and the client had limited understanding of US and Canadian market authorization requirements. These obstacles, combined with the fact that post-market requirements for medical devices are significantly different in new markets, led the manufacturer to consult the Mapi team of regulatory consultants to help it forge a way forward.
Mapi quickly developed a comprehensive regulatory strategy for the client that began with bridging the client’s existing ISO 13485 system to meet quality system requirements for both Canada (ISO 13485 CMDCAS) and the United States (21 CFR Part 820).
Having addressed the necessary quality system requirements, our consultants then developed regulatory filing strategies for the client that consisted of 510(k) submissions to the US Food and Drug Administration (FDA) and Class III medical device license applications to Health Canada.
Mapi also provided a full complement of post-marketing services — including US agent representation, FDA establishment registration and device listing, Health Canada medical device establishment licensing, and various support services as they were needed — to ensure the client’s success at every stage of all applicable regulatory processes.