Qmed Consulting A/S

We’re proud to share that Qmed has been nominated for Best Market Access Consultancy in Medtech of the Year at the MedTech World Malta Awards 2025. Although market access isn’t our primary service area, it reflects an essential part of what we help our clients achieve — taking innovative medical technologies safely, effectively, and successfully to market. For nearly two decades, Qmed has supported Medtech innovators with the full pathway from idea to approval — regulatory, clinical, and strategic. This nomination is a recognition of that integrated approach and the expertise of our entire team. We’re grateful to see our work acknowledged among so many respected peers in the industry.

Regulation rarely makes headlines — but it quietly shapes everything we do in Medtech.   Here’s a short summary of the most relevant updates this month, put together by Claudia Argenti, for those navigating development, documentation, and market access:   Europe → Regulation (EU) 2025/1920 introduces the Master UDI-DI for frames, spectacle lenses, and ready-to-wear reading spectacles, applicable from November 2028. → Version 4 of the Manual on Borderline and Classification under MDR and IVDR has been published. → Team NB released updated Best Practice Guidance for submissions under IVDR Annex II and III. → MHRA updated guidance on Clinical Investigations and How to notify the MHRA of your intention to carry one out. → EUDAMED 2.18.0 is now deployed.   United States → FDA published final guidance on Computer Software Assurance for Production and Quality System Software. → As of October 1st, all De Novo submissions must use the Electronic Submission Template (eSTAR). → Due to the current FDA shutdown, submissions requiring fees will not be accepted until funding is reinstated.   Other → ISO 18969 on Clinical Evaluation of Medical Devices is currently under development.   Each of these changes may seem technical, but together they remind us of how dynamic the regulatory landscape is — and how essential it is to stay aligned, especially for early-stage teams.   If you’d like to dive deeper into any of these topics, or hear how they may impact your next step toward approval, feel free to share your questions below — we're always happy to help clarify.   → Relevant links and official resources can be found in the first comment below.

New EU rules expand the scope of electronic IFUs — here’s what you need to know ↓   The European Commission has just expanded the rules for when electronic instructions for use (eIFUs) can replace paper instructions.   Under the new Implementing Regulation (EU) 2025/1234, the scope now includes: → Medical devices → Accessories for medical devices → Products listed in Annex XVI   The changes also applies immediately in Switzerland, as Swissmedic has adopted the EU rules without modification.   What does this mean for manufacturers? It’s an opportunity to modernise your IFU strategy — but it also raises questions about usability, compliance, and risk management.   If you’re considering switching to eIFUs or expanding their use, the key is to align early with regulatory requirements and plan for all use scenarios.   That’s exactly the kind of strategic planning we help our clients with — making sure great products reach the market without unnecessary delays.

Welcoming our new COO, Dr. Victoria J Cavendish 🥳 At Qmed, we’re committed to enabling better health — and that means not only partnering with the right clients, but also building the right team to deliver on our promise. As our projects have grown in complexity and scope, so has the need for strong operational leadership. Not to change who we are, but to strengthen what we already do best. That’s why we’re delighted to welcome Victoria as Qmed’s new Chief Operating Officer and Senior Principal Advisor. Victoria brings more than a decade of senior leadership experience in the CRO industry, with a proven ability to: → Align complex projects and teams towards shared goals → Elevate operational performance while maintaining quality and agility → Lead with both structure and empathy She understands that processes aren’t about bureaucracy — they’re about creating the right framework so great people can do great work. In her role, Victoria will focus on refining our operations, strengthening project governance, and developing our Qmed Project Management Model — always with the goal of delivering even better outcomes for our clients and the patients they serve. We’ve been patient in finding the right match for this role, and we’re confident we’ve found it in Victoria. Please join us in giving her a warm welcome to the Qmed team!

Qmed have been on an exiting journey with CorFlow bringing new technology to the patient.

At Qmed, our work is always about one thing: enabling better health.   That’s why we’re proud to support companies like CorFlow Therapeutics AG, who are pushing the boundaries of cardiovascular care.   CorFlow’s technology addresses a critical gap in heart attack management - immediate diagnosis of microvascular obstruction in the cardiac cath lab, right after the artery has been opened, and the ability to deliver potential therapies locally. It’s a groundbreaking approach that could change the way we treat acute myocardial infarction.   We’ve been fortunate to support CorFlow with FDA approval for their MOCA-II IDE Pivotal Trial - a major milestone in validating this new technology in the U.S.✅ Bringing innovation to market is never easy. It takes clinical insight, regulatory strategy, and a shared commitment to patient outcomes.   Congratulations to the CorFlow team for reaching this step🥳 We’re excited to follow the next phases of this journey.   → You can read CorFlow’s official announcement in the comment section.

Come and join a team of great people in a growing successfull company. We are looking for a CRA/Monitor for Scandinavia. We have interesting studies ongoing and in the pipeline. So if interested to learn more reach out. https://lnkd.in/dG3MEP4B

At this year’s #EuroPCR2025, one theme kept surfacing—regardless of whether we were talking funding, innovation, or regulation: CROs are no longer in the background. They’re shaping the path forward. As capital tightens and complexity rises, the expectations for CROs are growing: - Leaner trial design - Global regulatory insight - Support beyond execution—from strategic input to hands-on coordination - And the ability to move fast without compromising clinical or regulatory integrity We believe that’s a good thing. Because for medtech companies—especially those in early or clinical stages—working with the right CRO isn’t just about outsourcing. It’s about finding a partner who can create clarity, keep momentum, and act like an extension of your team. That’s what we aim to be. Thanks to everyone who met with Helene Quie last week. We’re bringing home new insights—and even more energy to help our partners build what’s next. Curious how we’re evolving our model to meet this moment? Let’s talk.

A moving train. A quiet moment. The Eiffel Tower in the background. Sometimes that’s all it takes to reflect on a week full of movement, meetings, and momentum. As #EuroPCR2025 wraps up, we’re heading home with plenty to think about – and even more to build on. This week we shared insights on: 🔹 What it really takes for medtech startups to secure funding 🔹 How AI is beginning to reshape interventional care – and where it still meets resistance 🔹 Why navigating MDR still causes delays – and what the latest data tells us 🔹 And how great conversations often happen outside the sessions It’s been 𝑒𝑛𝑒𝑟𝑔𝑖𝑠𝑖𝑛𝑔 to be part of the dialogue – and even better to connect with those of you building the future of medtech, one smart decision at a time. Early next week, Helene will share her full reflections on this year’s EuroPCR: The 𝐭𝐫𝐞𝐧𝐝𝐬 that stood out, the 𝐜𝐨𝐧𝐯𝐞𝐫𝐬𝐚𝐭𝐢𝐨𝐧𝐬 that mattered – and what they signal about where we’re 𝐡𝐞𝐚𝐝𝐞𝐝 next. 𝐔𝐧𝐭𝐢𝐥 𝐭𝐡𝐞𝐧: thanks for following along. And if you want to talk about how to apply these insights to your own roadmap, our inbox is always open.

We talk a lot about regulatory complexity in medtech – but now we have the numbers to show just how real it is. According to the latest (12th) NB survey (100% response rate from all 51 notified bodies), the MDR certification process remains long, inconsistent, and filled with preventable delays. Some key numbers stood out to me: 🔹 Just 𝟏𝟑 𝐨𝐮𝐭 𝐨𝐟 𝟓𝟎 𝐍𝐁𝐬 say that more than half of manufacturer submissions are complete at first review 🔹 Most companies wait 𝟏𝟑–𝟐𝟒 𝐦𝐨𝐧𝐭𝐡𝐬 for a certificate after signing an agreement 🔹 And 𝟓𝟑% 𝐨𝐟 𝐍𝐁𝐬 say the biggest delays lie not with them – but with manufacturers revising incomplete documentation Even more striking: 𝟒𝟐𝟏 𝐌𝐃𝐑 𝐚𝐩𝐩𝐥𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬 𝐰𝐞𝐫𝐞 𝐫𝐞𝐟𝐮𝐬𝐞𝐝 – with reasons ranging from misclassification to incomplete or incorrect data. It’s a tough system to navigate – especially for SMEs. But as someone working closely with early- and growth-stage medtech companies, I also see where things can be done smarter. Preparation matters more than ever. And so does having the right guidance. If you're currently preparing for MDR – or have already been through the process – what challenges have you run into? And what do you wish you'd known earlier? --- Link to survey in the comments