It is easy to make mistakes in the regulatory process that can delay market entry or incur unnecessary costs. With help from Emergo’s medical device regulatory consultants, you can pursue the most efficient regulatory route to approval and registration for your device, and maintain compliance with post-market requirements worldwide.
Medical device and IVD classification determination and assessments
Classifying your medical device is an important first step in the device registration process. Your device class dictates its regulatory roadmap, including required documentation, clinical data and study requirements, safety testing requirements, and more.
We have experience classifying medical devices according to rules in the US, Europe, Japan, Brazil, Canada, and many other markets. Our team performs the toughest classification assessments for novel, borderline, and combination products. If needed, we will work with you to seek feedback from regulatory authorities on the appropriate classification for your product through pre-submission meetings.
Navigate complex medical device and IVD regulatory requirements
Medical device companies face an evolving regulatory landscape: market entry comes with more challenges than ever and maintaining compliance requires ongoing effort. Our consultants bring deep familiarity with opaque regulatory processes, such as:
- European Clinical Evaluation Report (CER) preparation
- EU MDR 2017/745 gap assessments and transition consulting
- Risk management planning and ISO 14971 implementation
- FDA UDI compliance consulting
And much more. Explore all our regulatory consulting services.
Global market strategy for medical device companies
Because we work in so many different markets, we fully understand complex national regulations and where they overlap. We apply this knowledge for your benefit in a way that could not be achieved by working with separate consultancies or affiliates with limited local expertise. We will develop customized regulatory strategies that leverage your existing registrations. Whether you have one product or hundreds, we can help you expand your market reach to major and emerging markets worldwide.