RQM+ Introduces SMART Solutions Framework to Support Device and Diagnostics Programs

• RQM+ has launched SMART Solutions, a life-cycle partnership model designed to help medical device and diagnostics companies manage regulatory and development complexity.

• The model integrates regulatory, quality, clinical, reimbursement, and laboratory expertise within a single operating framework. 

RQM+ has introduced SMART Solutions, a life-cycle partnership model intended to help medical device and diagnostics companies manage increasingly complex development and regulatory requirements. The MedTech contract research organization (CRO) said the model provides a strategy-led framework that integrates regulatory, quality, clinical, reimbursement, and laboratory services across the product lifecycle. 

The framework is designed to support device manufacturers navigating evolving global regulations and development challenges. According to the company, the approach coordinates multiple service areas into a single operating model intended to streamline product development, regulatory approval, and commercialization processes. 

SMART Solutions is intended for complex device programs and high-growth therapeutic areas such as cardiovascular and neurology, as well as advanced technologies including implantable devices, combination products, software-enabled technologies, and in vitro diagnostic companion tests. 

The model also leverages RQM+’s clinical and laboratory capabilities, including those from Jordi Labs, an RQM+ company that provides analytical chemistry and extractables and leachables testing. The framework is supported by technology platforms and analytical data used to support regulatory and development decision-making. 

Through the SMART Solutions partnership model, RQM+ said it aims to help device and diagnostics companies address regulatory complexity while coordinating development, testing, and market access activities throughout the product lifecycle. 

“MedTech companies are navigating unprecedented complexity as regulatory expectations evolve, product innovation accelerates, and post-market expectations are expanding.”

John Potthoff, Ph.D., chief executive officer of RQM+.