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MDC guides IVD makers and their breakthrough technologies through the regulatory and clinical process to achieve market clearance. Our expertise is diagnostic technologies, our focus is microbiology, clinical chemistry, infectious disease and CDx products and instrumentation.
MDC establishes partnerships and trusted relationships with startup, growth and established company leaders and their teams.
Start-up
We gather market insights on your product concept, structure and build your quality system, develop a tailored regulatory strategy, identify potential risks and help define your plan to achieve market clearance.
Growth
We support ISO certifications, optimize QMS requirements, prepare for and support regulatory audits, eliminate repeat efforts that add costs and risk to clinical programs, anticipate regulatory hurdles and achieve product clearance.
Established
We are an extension of your team, freeing up your time by taking lead on projects. We facilitate introductions to clinical leaders and a global network of IVD experts and partners. We lead due diligence efforts to support your continued innovation and expansion.
Why MDC Associates?
- Accelerated Path to Market: Over 35 years of IVD expertise across a broad range of technologies and applications, guiding you through regulatory and clinical processes efficiently.
- Regulatory Expertise with Continuous FDA Engagement: Our established, positive relationship with the FDA helps you navigate submissions like Pre-subs, 510(k), De Novo, and PMAs smoothly.
- Practical Quality Expertise: We help you achieve your quality objectives without overwhelming your team with too much too soon. From eQMS to MDSAP and ISO audits, get expert advice and hands-on support.
- Extensive Clinical Site Network: Access a trusted network experienced in supporting high-complexity assays, CLIA-waived tests, and OTC diagnostics, providing fast and reliable performance validation.
- Your Trusted IVD CRO: Beyond strategy, we work as part of your team to execute critical steps in regulatory submissions, clinical trials, and quality systems compliance.
