Helps MedTech Companies Navigate MDR, IVDR, and AI-Enabled Device Development

PITTSBURGH: #ClinicalTrials--RQM+, a leading MedTech CRO offering regulatory consulting, clinical trial, laboratory, and reimbursement services, today announced the launch of SMART Solutions, a life cycle partnership model designed to help medical device and diagnostics companies manage growing regulatory and development complexity.

SMART Solutions introduces a strategy-led operating framework that unifies regulatory, quality, clinical, reimbursement, and laboratory expertise to support MedTech companies across the entire product life cycle to help reduce risk from early development through post-market.

“MedTech companies are navigating unprecedented complexity as regulatory expectations evolve, product innovation accelerates, and post-market expectations are expanding,” said John Potthoff, Ph.D., chief executive officer of RQM+. “SMART Solutions moves beyond traditional consulting by providing an integrated life cycle partnership that helps sponsors gain earlier clarity, reduce risk, and execute complex programs more predictably. This solution makes RQM+ one of the few MedTech CROs that can truly integrate device, software, lab, and regulatory strategy end to end.”

SMART Solutions addresses these challenges by replacing fragmented vendor-by-vendor workstreams with a coordinated life cycle model delivered through engagement options:

• Integrated SMART Solutions for small to midsize enterprises: Governed life cycle partnership integrating regulatory, clinical, quality, reimbursement, and lab services
• Functional SMART Solutions for larger enterprises: Targeted functional support within the framework

The model is designed for complex device programs and high-growth therapeutic areas, such as cardiovascular and neurology, as well as advanced product categories, including implantable devices, combination products, software-enabled technologies, and IVD companion diagnostics.

The framework also leverages RQM+’s growing clinical and laboratory capabilities, including Jordi Labs, an RQM+ company specializing in analytical chemistry and extractables and leachables testing, as well as AI-enabled technology platforms that are supported by proprietary analytical data.

By integrating regulatory strategy, clinical development, and lab science within a single operating model, RQM+ helps device and diagnostics companies accelerate development timelines, while improving life cycle governance and scalability.

MedTech companies can learn about SMART Solutions or request a life cycle consultation.

About RQM+

RQM+ is a leading MedTech service provider offering consulting, clinical trial, lab and reimbursement services, as well as technology solutions to support the entire product life cycle.

About Jordi Labs, an RQM+ Company

Jordi Labs, an RQM+ company, provides contract analytical services to leading consumer products, polymers, pharmaceutical, and medical device manufacturers. The company’s Ph.D. analytical chemists specialize in chemical identification, including extractables and leachables testing.

Fonte: Business Wire