MDC Associates, a trusted regulatory partner in the diagnostics and medical device industry, is expanding its support services to help companies navigate the evolving landscape of IVD device regulations.
-- MDC Associates, a trusted regulatory partner in the diagnostics and medical device industry, is expanding its support services to help companies navigate the evolving landscape of IVD device regulations. With a growing emphasis on regulatory compliance and quality assurance in the IVD sector, MDC Associates is stepping up to provide strategic guidance, technical expertise, and practical solutions to ensure clients are fully prepared for the challenges ahead.
Recent changes in global IVD regulatory frameworks—particularly the transition from legacy policies to more structured, risk-based approaches—have created a heightened sense of urgency for diagnostic manufacturers. In both the United States and international markets, compliance requirements are becoming more complex, demanding greater transparency, traceability, and documentation throughout the product lifecycle. These shifts are placing additional pressure on product developers, quality assurance teams, and regulatory affairs professionals to stay ahead of the curve.
MDC Associates recognizes that for many organizations, interpreting and implementing the latest regulatory expectations can be daunting. As a result, the firm has developed a targeted suite of consulting services designed to clarify regulatory pathways, reduce approval timelines, and mitigate compliance risks. This includes customized support for premarket submissions, regulatory strategy development, quality system alignment, and audit preparation—all tailored to meet the specific needs of IVD manufacturers and laboratories.
With decades of experience in regulatory affairs, clinical trial design, and diagnostic commercialization, MDC Associates brings deep industry knowledge to bear on complex compliance challenges. The team is well-versed in navigating U.S. FDA regulations under 21 CFR Part 809 and 820, as well as international frameworks such as the EU In Vitro Diagnostic Regulation (IVDR). This cross-functional expertise allows the firm to help clients proactively align with regulatory expectations and avoid costly delays or enforcement actions.
One key area of focus for MDC Associates is the increasing scrutiny of Laboratory Developed Tests (LDTs) under current and proposed regulatory structures. As the FDA signals greater oversight of LDTs—particularly those that function similarly to traditional IVDs—MDC is helping clients assess their risk profiles, update labeling and documentation, and evaluate when formal submissions may be required. This proactive approach helps clients maintain operational continuity while preparing for future policy shifts.
In addition to regulatory strategy, MDC Associates also supports the implementation of quality management systems (QMS) that meet the evolving standards for IVDs. Many diagnostic developers are facing new expectations around design controls, validation, and post-market surveillance. MDC helps these organizations build or refine QMS infrastructure that not only meets current regulatory requirements but is scalable for future growth. This includes support for SOP development, internal audits, CAPA systems, and training programs.
The firm’s approach is rooted in collaboration, customization, and real-world practicality. Rather than relying on one-size-fits-all templates, MDC Associates works directly with each client to understand their business model, product classification, and target market. From startups launching a first diagnostic product to established manufacturers expanding their global footprint, MDC adapts its support to align with each client’s technical and commercial objectives.
As IVD device regulations continue to evolve, organizations that invest in proactive compliance and strategic planning will be better positioned to compete, innovate, and earn the trust of regulators and customers alike. With a proven track record of success and a reputation for deep regulatory insight, MDC Associates stands ready to guide diagnostic developers through every phase of the regulatory journey.
Companies across the diagnostics ecosystem are turning to experienced partners for clarity and confidence to meet the demands of an increasingly regulated IVD landscape. MDC Associates continues to respond with the tools, expertise, and forward-thinking strategies needed to navigate the shifting regulatory terrain, ensuring clients are not only compliant but prepared for sustainable success in a rapidly changing industry.
About MDC Associates:
MDC provides life-saving diagnostic makers with the right support and catered solutions needed to make our world a healthier place. With over 35 years of experience, MDC Associates has the experience and expertise to provide unparalleled regulatory strategy and execution, full-service CRO planning and study management, quality systems design and implementation, and data management support, guidance, and analysis. Located on the technology corridor north of Boston, Massachusetts, MDC has earned a reputation of trust with companies of all sizes that develop, manufacture, and distribute in vitro diagnostic tests and instruments. The unique way MDC focuses its work and counsel guides clients in demonstrating safety and efficacy to achieve product approval, making MDC a valuable partner on the path to commercial success.
About the company: MDC provides life-saving diagnostic makers with the right support and catered solutions needed to make our world a healthier place. With over 35 years of experience, MDC Associates has the experience and expertise to provide unparalleled regulatory strategy and execution, full-service CRO planning and study management, quality systems design and implementation, and data management support, guidance, and analysis.
Contact Info:
Name: Kevin Roy
Email: Send Email
Organization: GreenBanana
Website: http://www.greenbananaseo.com
Release ID: 89161237
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