Expertise for Accurate Business Assessments
Assessing a medical device technology and/or company for the purposes of investment due diligence or planning for fund raising requires in-depth knowledge of regulatory and clinical strategies, reimbursement, quality systems, legal compliance (such as fraud and abuse compliance) as well as other industry specific requirements. RCRI knows medical devices, IVD’s, and combination products and the strategy, processes, and timelines involved in moving them from concept to successful commercialization.
Our team of qualified experts can help you avoid surprises by asking the right questions early in the due diligence process, so you can prepare more accurate business assessments and valuations.
Regulatory Affairs and Clinical Trial Design & Management
RCRI’s regulatory and clinical understanding can provide valuable insight to evaluating your investment and defining key steps to gain market access.
RCRI understands what is required to achieve optimal reimbursement for your product. We have the expertise to analyze available data to generate outcomes and health economics arguments.
Quality Systems & Compliance
RCRI understands global quality and compliance requirements and has significant experience creating quality systems that comply with FDA regulations as well as those of the European Union, China, India, Japan, Canada, and Australia.
Fraud & Abuse Compliance
RCRI can provide an analysis of the company’s compliance to legal requirements including contracts with hospitals, physician practices and physicians, fair market value payments to healthcare professionals, and reporting to state and federal governments, including the federal and state physician payment Sunshine Act and Medicare Secondary Payer law.