MDC Associates, a Full-Service Regulatory Consulting Company, Supporting the In Vitro Diagnostic and Medical Device Markets, is Acquired
Fran White and Joanne Lebrun will continue to serve in executive management roles.
BEVERLY, MASSACHUSETTS – May 2nd, 2019 – MDC Associates LLC, a full-service regulatory consulting company offering, regulatory, clinical research, quality systems and technical support services to in vitro diagnostics (IVD) and medical device companies, has been acquired by a corporation (MDC Associates, Inc.) lead by Joen T. Johansen. Mr. Johansen will serve as President & CEO of MDC Associates, Inc. while Ms. White and Ms. Lebrun will continue in their management roles as President, Regulatory Affairs and Vice President, Quality Systems, respectively. All current staff will continue with the company.
The acquisition ensures that MDC Associates remains an independent and agile organization that can continue to fully support its clients while also expanding its services. “MDC has built a reputation for providing the highest level of personalized services that is unsurpassed in the IVD industry. We want to maintain that while also offering new services that can guide clients to commercial success faster,” said Joen T. Johansen. “Joanne and I are excited to work with Joen and the entire MDC team on this next chapter for the company. Both of us look forward to continuing our work with clients and providing them the high-quality regulatory affairs and quality systems support that ensures successful regulatory and commercial outcomes. Joen is a perfect complement to MDC’s team,” said Fran White.
MDC Associates was founded over 30 years ago with the specific mission to help innovative IVD companies achieve regulatory approval and bring important medical advances to the market. Over the years, the company has worked on thousands of client projects and on average supports 5-10 clinical studies and 4-5 FDA submissions/clearances per year. Located in Beverly, Massachusetts just north of Boston, the company employs a highly-skilled and experienced group of regulatory affairs, clinical trials, and quality systems consultants, along with data managers and trainers
About Joen T. Johansen
Joen has more than 16 years of marketing, sales, business development and management experience in the IVD industry. Prior to MDC he was Head of Global Marketing for Accelerate Diagnostics, Inc. and was responsible for strategy, product management and marketing communications. Joen has worked to define, develop and launch more than 16 FDA cleared, CE-marked IVD products in the United States and Europe. Prior to joining the IVD industry Joen was a Healthcare Investment Banker with Lehman Brothers in London. Joen has degrees in Molecular Biology & Biochemistry and Economics from Wesleyan University.