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Clearance feels like the summit. It's base camp. Approval earns a complex device the opportunity to start the real climb, where clinicians adopt it and payers agree to pay for it. Optimize only for the approval letter and strong devices stall between clearance and the market they were built for. RQM+ plans the whole climb from day one, with regulatory, clinical, lab, and reimbursement operating as one team with one strategy. We’re built by former FDA and notified body reviewers, and backed by Jordi Labs, an in-house, FDA-recognized laboratory. Watch the story.

Most MedTech companies default to adding capability in-house because A) control feels safer, and B) outsourcing looks more expensive on paper. The most important questions to ask are about cost per outcome, and how fast you can reach it. RQM+’s MedTech Outsourcing Toolkit gives you the decision frameworks, self-assessments, and checklists to decide what belongs in-house, pinpoint where your current model is strained, and set the governance and partner criteria that lower risk across your product life cycle. Inside, you get a true cost framework for FTE versus outsourced work, an outsource-or-own scoring matrix, a life cycle map, and readiness scorecards for surge events and partner selection. Download the free toolkit.

Most MedTech companies default to adding capability in-house because A) control feels safer, and B) outsourcing looks more expensive on paper. The most important questions to ask are about cost per outcome, and how fast you can reach it. RQM+’s MedTech Outsourcing Toolkit gives you the decision frameworks, self-assessments, and checklists to decide what belongs in-house, pinpoint where your current model is strained, and set the governance and partner criteria that lower risk across your product life cycle. Inside, you get a true cost framework for FTE versus outsourced work, an outsource-or-own scoring matrix, a life cycle map, and readiness scorecards for surge events and partner selection. Download the free toolkit.

For high-risk implantable and interventional devices, biological safety is a risk-based strategy. At RQM+, we build it alongside your clinical evidence from the start. In this on-demand session, Jordi Labs' Kaitlin Lerner and RQM+ cardiovascular lead Dr. Deb Morley show how to plan biocompatibility and clinical evidence together from concept through post-market, so the biological, clinical, and overall device risks line up where regulators want to see them. Watch on demand.

For high-risk implantable and interventional devices, biological safety is a risk-based strategy. At RQM+, we build it alongside your clinical evidence from the start. In this on-demand session, Jordi Labs' Kaitlin Lerner and RQM+ cardiovascular lead Dr. Deb Morley show how to plan biocompatibility and clinical evidence together from concept through post-market, so the biological, clinical, and overall device risks line up where regulators want to see them. Watch on demand.

48 hours to go. On September 17 at 11am ET, RQM+ and Scarlet, the notified body specializing in AI and software as a medical device, will go live to answer your AI regulatory questions in real time. You ask, they answer. If your team is mid-submission and trying to keep up with a moving regulatory line, this is the conversation to join: In-flight EU MDR changes The EU AI Act ISO/IEC 42001 versus EN 18286 IMDRF's developing AI lifecycle framework The conformity pitfalls Scarlet is seeing right now Join Jonathan Gimbel (RQM+), Samy Puccio (RQM+) and Sandy Wright (Scarlet), moderated by our own Jaishankar Kutty, Ph.D. Register now → https://lnkd.in/g4x8bxyz #MedTech #AIinMedicalDevices #EUMDR #EUAIAct #SaMD #NotifiedBody #IMDRF