We Partner with the Best in MedTech to Bring Quality Products to Life

By leveraging the best people, processes, and tools to guide them over regulatory Food and Drug Administration (FDA) hurdles.

Let's Get Your Product Through the FDA.

Talk to the FDA, Before You Talk to the FDA™

MedTech Impact Partners is a Medical Device Regulatory Strategy Consulting Firm.

We leverage deep executive-level experience from the USFDA, private sector and world-class research to deliver expert insights for companies, law firms and investors. Our work results in improved compliance for medtech companies, expert interpretation of FDA laws, regulations and policies for law firms, and enhanced diligence for venture capital firms.

Our Services

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.

Learn more

Why Partner with MedTech Impact Partners?

MIP is a Global Leader in Regulatory Strategy

Canada
United States
Honduras
Germany
Norway
Spain
Zimbabwe
Malawi
Tanzania
Namibia
China
Japan
Republic of Korea

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 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.

Our Clients

Leveraging 20 years of government and private sector experience, MIP is the partner you need to make it to the finish line.

Emerging Trends
Leading Research
Thought Leadership
Industry Insights
Proven Strategy
Philanthropic Innovation

Thought Leaders in Research & Development

At MIP, we offer leading insights into regulatory trends. Our research studies and findings make us a highly sought firm, recognized for being ahead of a rapidly changing medtech landscape. We’ve shared examples of our latest collaborations that are making industry headlines.

For Cutting-Edge Innovations, the US Pulls Ahead of the EU in Medtech Regulation

The $550 billion global medtech industry is becoming connected and digitized at an unprecedented rate, posing challenges for regulatory agencies and payers that often lack the expertise and capacity to keep pace with rapidly evolving technologies. To assess the current regulatory landscape for medtech and digital innovation, BCG and UCLA Biodesign collaborated on a research project examining the review process for medical device registrations. UCLA Biodesign surveyed more than 100 senior executives at medtech companies, representing 105 successful medical product registrations between 2010 and 2021; BCG assisted in designing the study, offering insights, and preparing the report. The results show that a sea change is underway in the industry with regard to the preferred path to bring new products to market.

Learn more