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.
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.
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.
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.