3 Fundamental Risks to Your Success


Every new diagnostic and medical device faces three fundamental risks. MDC Associates will partner with you to help de-risk all of them and successfully move your project forward.

Product


Does the product deliver the features that customers require for routine clinical use?

Regulatory


Is there a regulatory path that will allow for timely approval at a reasonable investment?

Commercial


Will the Go-to-Market strategy lead to high adoption at a price that will ensure a positive ROI?

We Help Companies at Every Stage


Startup

New to the market and with limited internal regulatory, quality systems or commercial expertise

  • Customer feedback and regulatory guidance to finalize development.

  • Quality System development

  • Understand regulatory pathway and criteria for approval

  • Estimate budget for clinical study and submission

  • Identify study sites, manage studies and regulatory submission

Growth

Need additional regulatory expertise and help to ensure quality system meets requirements

  • Manage regulatory strategy and clinical studies to expand product portfolio

  • Expand claims for existing products

  • GAP analysis and CAPA implementation for current QMS

  • Go-to-Market strategy and support

Established

Supplement existing expertise with subject matter experts and customer implementation support

  • Subject matter experts outside your organizations existing areas of expertise (e.g. Microbiology, CLIA-waiver, IVDR)

  • Internal Quality Audits (IQA)

  • New lab customer implementation support

  • Video training and performance verification

MDC Associates maintains full client confidentiality.

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