Regulatory Affairs

The regulatory landscape is ever changing. Medpoint’s team of former FDA and industry experts ensure compliant navigation of that landscape.

Streamlining Regulatory Affairs

Medpoint’s Regulatory Affairs experts bring years of experience with a number of different healthcare product submissions. Our consultants advise clients on each phase of the development process including design controls, failure modes effects and analysis, benefits-risk analysis, and submission strategies to ensure a successful 510(k) or PMA.

We can provide guidance on necessary preclinical and clinical data to ensure superior evidence of safety and efficacy in preparation for a premarket submission. Medpoint supports domestic and foreign submissions and will carry you through each step of the process. Evolving regulatory requirements, such as EU MDR, dictates that you have a seasoned and knowledgeable professional on your side. Medpoint provides the expertise you need to ensure a smooth and successful process to achieve premarket approval.


Technical Writing

Medpoint’s regulatory professionals offer adept technical writing support for tasks such as creating a new drug application for the FDA or assembling a compliant technical file for upcoming EU MDR requirements. Whether crafting original drafts or providing editing assistance, we help prevent common issues with domestic and international regulatory bodies.

From FDA Qsubs and investigational device exemptions (IDE) to clinical evaluation reports (CER) and risk management strategies, we address various technical writing needs.
Medpoint ensures clients confidently navigate the regulatory landscape.

Contact Us Today

Contact us today to discuss your needs and discover the difference our world-class expertise will make for your business.