We are living through a revolution in medicine where new gene therapies and other innovative treatments can vastly improve the quality and longevity of patients’ lives. To ensure these breakthroughs are used properly and are available to those who will truly benefit from them we need new and improved diagnostics and devices.
Our Vision
Innovators anywhere in the world should have the opportunity to bring their products to market to help improve medical care for all of us.
Our Mission
To utilize our expertise and experience to help these innovators navigate the complex requirements to ensure quality in their products and to achieve both regulatory approval and commercial success.
Our Experience
At the core of MDC’s services are our experienced professionals. Their focus is to utilize their expertise to complement our clients’ knowledge of their products to chart a path forward to achieve your goals.
With over 30 years of diagnostic and device experience we have broad knowledge across product areas, technologies, laboratories types and international standards and regulatory requirements.
Our Culture
We work in a highly collaborative environment both internally and with clients to ensure that the best ideas are brought to projects and that we systematically tackle the challenges that we will inevitably face.
We are honest, open and transparent and we strive for a workplace where everyone feels engaged, supported and heard.
Our Team
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Joen T. Johansen
President & CEO
Joen T. Johansen
President & CEOJoen 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.
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Joanne Lebrun
Vice President, Quality SystemsJoanne Lebrun
Vice President, Quality SystemsJoanne has spent the last 17 years helping expand MDC Associates’ business to include both quality systems development and customer training support services. Joanne is an expert in medical device/IVD quality systems and applies that knowledge to support MDC’s QA clients every day. In addition, Joanne has over time taken on the role of day-to-day operations at MDC and manages all administrative and project related activities for the company. Joanne holds an MBA from Carnegie Melon University as well as a degree from Rice University.
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Fran White
President, Regulatory AffairsFran White
President, Regulatory AffairsFran is a highly regarded IVD FDA regulatory expert who founded MDC Associates LLC more than 30 years ago to provide her expertise to the broader IVD industry. Under her direction and leadership, the company has grown and extended service offerings to include quality systems development, managing clinical trials and developing and supporting IVD customer training. Prior to MDC, Fran worked in a variety of quality, regulatory and customer services roles for Gibco Laboratories, as well as in the clinical microbiology laboratory at New England Deaconess Hospital (now Beth Israel Deaconess Medical Center).
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Michael Smith
Manager, Regulatory & Clinical AffairsMichael Smith
Manager, Regulatory & Clinical Affairs
Careers
We are always looking for individuals who are passionate about helping clients make a difference in patient lives.
Please contact us for available opportunities
