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.
Does the product deliver the features that customers require for routine clinical use?
Is there a regulatory path that will allow for timely approval at a reasonable investment?
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
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
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
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