MDC Associates

About MDC Associates

MDC Associates is a consulting firm in Beverly, Massachusetts, that works with companies developing diagnostic tests. Its Google categories place it as a corporate office and a research and product development firm.

What a diagnostics consultant in Beverly takes on

An office like this one helps a company with a new test get it studied, cleared and kept in compliance. MDC's own description names regulatory affairs, quality systems and clinical research among its areas. It also lists hands-on help such as specimen sourcing, analytical studies and setting up a CLIA lab.

The company spells out IVD as in vitro diagnostic devices. Nearly all of its work centers on them, from early studies through support after a product reaches the market.

Beverly had 43,363 residents in 2025, per the Census Bureau. The city sits in Essex County.

Where MDC Associates puts its work

The company describes itself as a contract research organization built for IVD companies. It splits its work into three groups: clinical, regulatory and quality. On the clinical side, it says it runs studies from the planning stage to closeout, including usability, analytical and CLIA-waiver studies.

On the regulatory side, its website names FDA filings such as 510(k), de novo and PMA submissions. It also lists registrations abroad with Health Canada, under UKCA and under the EU's IVDR rules. Its quality team, the company says, helps clients plan, audit and repair their quality management systems as the FDA moves to a quality rule aligned with ISO 13485.

The firm names point-of-care and over-the-counter tests, infectious disease, and clinical chemistry and hematology among its fields. Joen Johansen leads the company as president and CEO. Brenna Sullivan directs its clinical operations.

The company says a first contact starts with booking time with its team to go over a client's goals for a product.

In the business's own words

IVD Expertise | Medical Devices | Regulatory Affairs | CRO | Quality Systems | On-Market Support | Market Access | Market Research | Clinical KOL Network | Software Guidance | CLIA Lab Setup | Analytical Studies | Contract Manufacturing | Specimen Sourcing

From the business's own words on its Google listing, October 2026.

What this listing mentions

• Wheelchair accessible entrance
• Wheelchair accessible parking

From the business's own words on its Google listing, October 2026.