Regulatory Services

Medical Device Regulatory

When you partner with us for support with regulatory services, we listen to your needs to help you determine your regulatory path to approval. The regulatory process can be a long one, but throughout we will treat you like a colleague.

We can help you develop strategies for everything from product development to final marketing approval, post-approval support, and quality system improvement and remediation. At every stage, we use sound science and in-depth knowledge of regulators and regulations to show how your product and processes can meet regulatory requirements.

We’re here to help.

Some regulations may seem obvious at first glance, but obtaining market authorization rarely is. When you partner with us, our regulatory services team will:

• Interpret the regulations and any guidance that applies to your device using our in-depth knowledge of past and current practices, to find the least burdensome way to achieve your end goal: getting your product to market.
• Apply a scientific risk-based approach to develop your regulatory strategy and the data required for marketing authorization.
• Interface with regulators to help them understand your product, its benefits, and its safety profile.
• Write your submission with well-practiced regulatory writing skills, developed with decades of experience, carefully explaining your device and your data in a way that regulators can quickly grasp.

Why work with MED Institute?

• Our regulatory services team has extensive experience in all phases of development, so we understand the bigger picture.
• Our experience with regulators is both deep and broad. Our science- and patient-focused approaches resonate with regulators.
• Our team approach ensures you get the benefit of our company’s experience. Our regulatory team collaborates with other service areas within MED Institute, such as Engineering and Clinical, to keep abreast of the latest technological developments.
• Our standards are high. Regulatory submissions are peer-reviewed within MED Institute before being sent to regulators.

Did you know MED Institute …

• • Has worked on 1 original NDA and 12 FDA-approved original PMAs, including the PMA for the first FDA-approved coronary stent and the PMA for the first FDA-approved drug-coated peripheral stent?
  • Has worked on over 40 IDEs?
  • Personnel have helped clear over 70 original 510(k)s over the past 25 years, in most every division of FDA’s Office of Device Evaluation (now Office of Product Evaluation and Quality)?
  • Obtained the first ever Humanitarian Device Exemption from FDA in 1997 and more recently obtained another in 2013?
  • Has informed the ISO Working Groups responsible for the latest versions of multiple ISO 10993 standards, including part 18 concerning chemical characterization of medical devices, part 12 on sample preparation, and part 17 on toxicological risk assessment?
  • Has a 15-year history of deep involvement with FDA-PMDA’s Harmonization By Doing group, including simultaneous review of marketing applications for a drug-coated stent?