Our Solutions

At MIP, our areas of expertise lead to positive outcomes for innovators and investors. Our focus is centered on developing sound regulatory strategy, diligent review, and managing risks for clients.

  • We develop a regulatory path that manages business risks and supports long-term company growth.

  • We prepare the company for effective interactions with the FDA. We focus the interactions on getting the answers you need for clearance or approval. Specific support includes: FDA response review, meeting preparation, and meeting representation.

  • We evaluate potential acquisition targets to identify gaps in regulatory submissions, quality management systems, and compliance.

Compliance and Change Management

MIP consultants conduct an assessment of the regulatory and business risk and provide comprehensive solutions. We proactively manage risks that accounts for patient safety, product quality, customer retention, on time delivery, and regulatory compliance.

Expert Legal Review

We support cases related to medical device and FDA matters. Our managing partner brings 20 years of experience reviewing over 1,000 FDA submissions, teaching, conducting research and working for all sizes of medical device companies. We can work on legal reviews, support depositions or participate in expert trial testimony.

Training and Education

Experienced consultants build customized lectures to Universities and Corporations on topics related to medical device development. Our focus is on the practical realities involved in bringing a technology from concept to the production-level product. The training and educational opportunities are delivered through webinar, classroom setting or intimate round table format.

Why Partner with MedTech Impact Partners?

We Offer Regulatory Support for MedTech Firms.

At MedTech Impact Partners (MIP), we offer our clients more than 20 years of government and private sector experience that is unmatched. Our suite of services take early-stage MedTech companies over regulatory hurdles and helps them deliver on key milestones.

We Offer a Solutions Driven Approach.

We engage our clients to gain a deep and clear understanding of their needs. This rigorous discovery process serves as the starting point to develop solutions that deliver for the client and meet the requirements of the regulatory agency. Consultants use a consistent set of tools to solve your problems, consider an exhaustive range of factors to manage risks and unearth opportunities for the customer.

We Meet You Where You Need Us Most.

We serve innovators around the world and provide services that meet unique needs and timelines.