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PRRC: The Hidden Champions of MDR Manufacturers Every medical device manufacturer under MDR must appoint a Person Responsible for Regulatory Compliance (PRRC). Sounds simple? In reality, this role is one of the most critical and high-stakes positions in regulatory affairs. Who qualifies as a PRRC? What are their exact responsibilities? And most importantly, what are the personal risks? Let’s analyse it. 1. What is a PRRC? ↳ A legally required role overseeing MDR compliance. ↳ Manages regulatory, quality, and vigilance activities. ↳ Mandatory for manufacturers and certain authorized representatives. 2. Minimum Requirements to Become a PRRC ↳ Degree + 1 year of experience in regulatory or quality. ↳ Or 4 years of professional experience in medical devices. ↳ Experience must be specific to MDR-related tasks. 3. Key Responsibilities of a PRRC ↳ Confirms product compliance before market release. ↳ Maintains and reviews technical documentation. ↳ Oversees post-market surveillance and vigilance. 4. Internal vs. External PRRC ↳ Internal PRRC is required for most manufacturers. ↳ Small companies (<50 employees or <€10M) may outsource. ↳ External PRRC must be permanently available. 5. PRRC Personal Liability ↳ PRRCs are usually not personally accountable for compliance failures. ↳ Liability depends on contracts and national laws. ↳ Clear documentation is key to protecting oneself. A skilled PRRC plays a crucial role in regulatory success. They make sure compliance is always maintained. Products are only released when they fully meet safety and quality standards. Post-market risks are continuously monitored and managed. The PRRC isn’t just a title. It’s the company’s regulatory backbone. P.S. Does your company have an internal or external PRRC? ⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡ MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference. I'm Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed. Let's connect and collaborate to streamline regulatory work for everyone! #automation #regulatoryaffairs #medicaldevices

EU MDR and IVDR: the “special” head of the certification hydra 🐉🇪🇺 Founders often tell me the same thing: FDA feels like a path, EU feels like a puzzle. In the US you can follow one main playbook and one agency conversation. In Europe you have a regulation, guidance, standards, a Notified Body, and country-level pieces that all matter at once. It is not that the EU is impossible, it is that the roadmap is less explicit unless you build it yourself. How to turn the EU head into a usable route: ↳ Separate what is law vs what is guidance: MDR or IVDR text, then Implementing and Delegated Acts, then MDCG documents. Treat them differently in your plan. ↳ Track standards like a product dependency: watch harmonisation status (Official Journal), versions, and transition dates so you do not test to yesterday’s edition. ↳ Check if Common Specifications apply to your device category. If they do, they can change what “good enough” looks like. ↳ Build a “country overlay” sheet for your launch markets: language and labeling needs, local registration expectations, incident reporting pathways, and any extra national steps around clinical investigations. ↳ Treat clinical and data as national too: ethics submissions, site contracts, patient info sheets, and how GDPR expectations are implemented in the countries you run studies in. ↳ Ask your Notified Body what they will rely on most: which guidance, which standards, and what their sampling focus is. Document it and build to it. ↳ Maintain one living index: every guidance or national requirement you rely on, with a link, date, and where it is implemented in your QMS or tech file. ⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡⬡ MedTech regulatory challenges can be complex, but smart strategies, cutting-edge tools, and expert insights can make all the difference. I'm Tibor, passionate about leveraging AI to transform how regulatory processes are automated and managed. Let's connect and collaborate to streamline regulatory work for everyone! #automation #regulatoryaffairs #medicaldevices

Carmen Messerlian spent more than 20 years studying reproductive and environmental health before she started Vie Science She kept seeing the same problem. We wait until people are struggling to conceive before anyone pays attention to their reproductive health. Vie is changing that. It is a fertility intelligence platform that brings together data across women, men and couples. When Carmen came to us, she had the science, the vision and a complex product to build. Our job was to understand that complexity and turn it into something people can actually use. Today Vie is ready for commercial launch. Hearing Carmen say we operated as an extension of her team means a lot to everyone at Bitsol We are just getting started together. Founders building in women's health: what was the hardest part of turning your science into a product people use? #FemTech #ReproductiveHealth #WomensHealth #WHIS2026 #WomensHealthInnovation #WomensHealthUniverse #WHU

A week ago, 384 people from 38 countries joined us live for the Validated AI for Pharma Summit. I opened it, gave a talk, moderated the roundtable and closed it, so it was a long day. Three things from it have stayed with me. Data came out on top in our live poll. When we asked what stops people from calling their AI setup validated, the most common answer was data quality and standards. I wasn't surprised, but it was good to see it written down. Most teams are still early. Only 4 of 27 people who answered run validated AI in GxP today. Everyone else is exploring, piloting, or running something that isn't validated yet. In regulated work, going step by step is the right pace. A third of respondents said nobody at their company clearly owns AI adoption. We talked about this in the roundtable too, and I think it needs an answer before any of the technical stuff does. Big thanks to our speakers: Chris Decker, Peter K., Ben O'Brien, Eric Nantz, Will Landau, Ross Sharp, CFA, Michael Rimler, Magalie Wasem Tréguer, Pascal BOUQUET Gabriel Eichler, PhD, David Foster and André Veríssimo, PhD. Thanks also to Srinivas V. and Sarah Banks for the roundtable, to Dina P. and Jakub Wąsala for hosting, and to Jakub Wąsala and Vedha Viyash for running the Workshop Day with me. We didn't get to every question in the chat. If something stuck with you, or you didn't agree with something you heard, tell me. Leave a comment or DM me. I'm happy to get on a call and talk it through. In two weeks we're doing a separate webinar with Anna De Feo. I'll share details soon. All sessions are on demand here: https://lnkd.in/gNWH9BVA #ValidatedAI #PharmaAI #GxP

I've spent years looking at what senior living operators engage with. Which emails they click through on, what content resonates with them, which webinars they stay on until the end, which questions come up on demo calls. One of our most engaged content concepts this year was The Black Hole. It drove more demo requests to our product than almost anything else we put out. Why did it land? 1. It named the right fear. Given the choice, people prefer a risk they can measure over one they can't, even when the odds are no better. A known turnover problem is something you can plan around. Turnover with no explanation is the version operators dread, because there's nothing to act on. 2. It described something they'd already lived. It lives in your organization. Your employees are getting pulled into it. And most of the time, nobody knows why. Operators recognized it the moment they read it. 3. It showed them the way out. People stay where they feel capable and heard. They leave where they feel thrown in and ignored. If you never ask, you never track the answers. The Black Hole only stays dark if nobody turns the lights on. If you run a community: do you actually know why your last three employees left?

Newsflash: ik heb een super fijne huisarts! En toch heb ik Flouria Health opgericht… We krijgen wel eens de vraag: maar hoezo zou ik voor dit soort zorg niet gewoon naar de huisarts gaan? Antwoord: als jij een fijne huisarts hebt, die zich interesseert voor dit onderwerp en de mogelijkheid heeft om hier tijd voor te maken, dan zit je waarschijnlijk helemaal op je plek. Maar de realiteit is meestal anders. Huisartsen worden overvraagd, ondergewaardeerd en hebben vaak meer urgente zaken aan hun hoofd met de 30 patiënten die zij zien op een dag… Hormonen zijn complex, dus uitgebreide afstelling op zaken zoals hormoontherapie is gewoon heel veel gevraagd bovenop het takenpakket dat ze al hebben. Dus dat pakken we anders aan bij Flouria Health. Niet alleen cliënten krijgen meer aandacht, maar artsen ook. Ze krijgen de tijd en ruimte om hun werk met aandacht te doen. En dat resulteert in dat diezelfde huisarts bij Flouria hoort: “Ik heb een potje zitten janken van opluchting” “Eindelijk een plek waar ik gehoord word en zicht heb op verbetering” “Ik voel me zo begrepen” Daar doen we het voor. En tuurlijk zien we ook huisartsen met oude denkbeelden (mijn persoonlijke favoriet is “ik geloof niet zo in de overgang”) maar in de basis zien wij onszelf als een belangrijke aanvulling op het bestaande systeem, niet als een vervanging van. Dus, ben jij - net als ik - happy met jouw huisarts, maar vind je het daarnaast fijn om met een arts te werken die veel weet van hormonale klachten? Bij ons ben je welkom! En je huisarts ook ;) 𝗪𝗮𝘁 𝗯𝗶𝗲𝗱𝗲𝗻 𝘄𝗲? Bij Flouria Health boek je eerst een vrijblijvende intake, vervolgens krijg je hormoon & bloedonderzoek en een uitgebreid eerste consult. En daarna? We blijven minimaal een jaar betrokken. Geen losse afspraak en succes ermee, maar persoonlijke begeleiding over tijd. Kijk voor meer info op onze website: https://flouria.health/nl/ ps. foto van mijn bloeddruk, even bij de huisarts binnengelopen om te laten meten. Kan gewoon, wat een toppers. <3

Yesterday I had the privilege of presenting at the HCAOA 2026 National Home Care Conference in Orlando, sharing findings from the 2026 Activated Insights Benchmarking Report, now in its 17th year. This years report draws on 1,080 survey respondents. Three findings stood out: 1) Client experience drives revenue. Client satisfaction reached 9.09, its fourth straight year of improvement, and word-of-mouth remains the #1 source of new business. 2) Caregiver turnover is stuck at 75.5%, and benefits alone wont fix it. Benefits adoption hit a multi-year high of 94.1%, yet turnover barely moved. Wages remain the strongest lever, and recognition, the lowest-scoring category we track, is the most overlooked. 3) Measurement separates top performers. Agencies that track their funnel are pulling ahead. Those converting 45%+ of inquiries to admissions report $3.99M in median revenue, vs. $2.38M for those below that mark. Thank you to Home Care Association of America for the opportunity, and to everyone who joined the session and shared how they're earning referrals and retaining caregivers. Get the full 2026 Benchmarking Report: https://lnkd.in/e37b8mWK

Warm, he? Tijdens mijn studententijd nam ik op dit soort dagen de trein naar Den Haag, om dagenlang te “studeren” op het strand in Scheveningen. In de brandende zon. (Het zal niemand verbazen dat ik vrij lang over mijn studie heb gedaan, maar dat terzijde). Nu kan ik me er niks meer bij voorstellen; dat ik het urenlang volhield in de volle zon. Is dit ook deel van het ouder worden? Tegenwoordig hop ik van schaduw naar schaduw en draag ik een hoed/pet als het even kan. Bij Flouria Health behandelen veel vrouwen met “warmteklachten”. Ik heb zelf nog nooit een opvlieger gehad, maar als het enigszins lijkt op hoe ik me deze dagen voel, kijk ik er niet naar uit. Dus voor iedereen die met dit weer moet dealen met warmteklachten: neem een ijsje en ik denk aan jullie! <3 https://lnkd.in/eG8-bHBu

Die Helios Endo-Klinik in Hamburg feiert heute ihr 50-jähriges Jubiläum. Herzlichen Glückwunsch an Thorsten Gehrke, Johannes Rasche und Philip Wettengel und das gesamte ENDO-Team zu diesem Meilenstein. Und vor allem: Herzlichen Dank für Ihren täglichen Einsatz für unsere Patientinnen und Patienten! Seit ihrer Gründung 1976 hat sich die Helios ENDO-Klinik zu einer internationalen Topadresse für Endoprothetik entwickelt. Heute führen dort unsere Teams jedes Jahr rund 9.500 OPs in den Fachbereichen Orthopädie, Sportmedizin und Wirbelsäulenchirurgie durch und verhelfen Menschen zu neuer Mobilität. Mit mehr als 200.000 implantierten Gelenkprothesen seit Gründung liegt die Klinik deutschlandweit an der Spitze. Bei der Behandlung komplexer Gelenkinfektionen gehört sie weltweit zu den führenden Zentren. Bei meinem Besuch vor einem halben Jahr konnte ich selbst erleben, was die Helios ENDO-Klinik besonders macht: - höchste medizinische Spezialisierung, - moderne Techniken und Behandlungsmethoden, - enge Verbindung von Forschung, Innovation und fachübergreifender Zusammenarbeit, - und vor allem Teams, die medizinisch und menschlich herausragend sind. Diese gebündelte Kompetenz hat hunderttausenden Patientinnen und Patienten geholfen, Mobilität, Selbstständigkeit und damit verbunden Lebensqualität zurückzugewinnen. Was die ENDO-Klinik seit Jahrzehnten erfolgreich vorlebt, ist zugleich Kern unserer Cluster-Strategie bei Helios Kliniken GmbH: medizinische Expertise zu bündeln, Spitzenmedizin weiterzuentwickeln und so die bestmöglichen Ergebnisse für Patientinnen und Patienten zu erzielen. Feiern Sie schön! #FreseniusCommittedToLife #TeamFresenius

Ireland's Presidency of the Council of the European Union comes at an important moment for Europe's life sciences sector. With competitiveness, innovation and the Biotech Act high on the agenda, the next months offer a real opportunity to turn ambition into action. In my conversation with Euractiv, I discuss what this means in practice: building a European policy framework that encourages research and incentivizes investment in health innovation, and strengthening the conditions that allow therapeutic breakthrough to thrive across Member States. A predictable, innovation-friendly environment is essential for Europe’s leadership in life sciences and, above all, for patients and healthcare systems. I look forward to continuing the conversation over the coming months. #IrishPresidency #Competitiveness #BiotechAct #EUHealth

For those of us who have been in the biopharmaceutical industry for a long time, the experience of working on "me too" or "me better" drug discovery programs is commonplace, and the privilege of working on novel targets supported by powerful causal biology, such as osteoprotegrin, sclerostin and PCSK9, is quite quite rare. 38 targets now have more than 50 programs against each of them, while the number of novel targets advanced per year fell from roughly 100 in 2015 to about 30 in 2024. For 8 years insitro has been working to reverse this trend. Please read about our journey in the first of a multi-part series "Deep Phenotype: Scaled Biology, Deep Causality": https://lnkd.in/gRyMFA2y #AI #ML

Huisstofmijtallergie bij kinderen wordt niet altijd direct herkend. Hoe onderscheid je allergie van een gewone verkoudheid?🤧 Op 20 oktober bespreekt kinderarts-allergoloog dr. Joyce Emons dit en meer tijdens het webinar ‘Huisstofmijtallergie bij kinderen’. Meld je nu aan via onderstaande link https://lnkd.in/ephR4TMq

Een onzichtbare trigger in de kinderkamer kan grote impact hebben op het dagelijks leven van een kind. Tijdens het webinar op 20 oktober bespreekt dr. Joyce Emons hoe je huisstofmijtallergie bij kinderen herkent en behandelt. Meld je nu aan via https://lnkd.in/eQZp56P5 nbsp;

This past week, we registered a formal comment with the FDA in response to the proposed pilot program to use AI in early-stage clinical trials. In short - we maintained our position that AI output is only as good as the input. If you've spent any time in health informatics, you know that there's a lot of junk that passes for information. There is so much promise in accelerating the pace of life-changing therapies brought to people who need them - but to do this well, we need to make sure that we inform the models with context and patient-driven data that reflects whether people are actually feeling better in their everyday lives. Imagine - if we had that simple information for every drug - how easy this process could be! https://lnkd.in/gxDX9UDr

Enjoyed a morning spent at Pfizer Innovation in Cambridge yesterday with biopharma leaders, discussing paths forward for high-impact implementation of digital tools for research & launching of therapies. This is a key area for directly relating drug development to what individual people need. As Brett Hauber said, which I resonated with deeply: "Are we measuring something that matters to patients?...What is the impact of this condition on your life, what would make it better, and how can we measure this? We often start with a measure first..but does it truly matter?" (Slide from Click Therapeutics, Inc.)

Every Data Monitoring Committee (DMC) has the same job — to protect participants and preserve the integrity of the study. But that doesn’t mean one size fits all. The questions a DMC asks in an oncology trial will look very different from those in a vaccine study, a cardiovascular outcomes trial, or a rare disease program. So how can sponsors prepare and support their DMCs when disease context changes so much? Cytel's latest ebook looks at how DMC oversight works across: • Oncology • Immunology • Vaccines • Cardiology • Neurology • Rare diseases and orphan indications • Special considerations beyond therapeutic area You can read the full eBook via the link below 👇 https://lnkd.in/eX4f3kPZ

I recently had the pleasure of moderating a webinar with my friends Sicknee Daher, BSN, RN, Clinical Practice Director, Perioperative Services at Henry Ford Health, Vangie Dennis MSN, RN, CMLSO, CNOR, FAORN, FAAN, Perioperative Nurse Executive and Consultant at Perioperative Consultants, LLC, and OR Today. Our conversation was candid, the discussion was interesting and real, and the message is clear: Nurses want AI. And they want it to relieve the problems they actually experience bedside. In Vangie’s words, they want to “stop counting widgets,” and “be nurses.” They want to stop tenured nurses from burning out, and help younger nurses get onboarded faster. And they want a seat at the table when hospitals are purchasing AI solutions. We covered all of that, and more, so if you missed it, we have an on-demand video you can watch here → https://lnkd.in/gdHYkwVB Or you can check out our blog recap and read up on all the details → https://lnkd.in/g3kHvJVN #AIForNurses #ORTodayWebinar #ORToday

🎙️Dans ce nouvel épisode de #ClarianeVoices, Stéphane Hubert revient sur les différentes étapes qui l’ont conduit à sa récente prise de fonction à la tête de La Cambre, à #Bruxelles, un établissement spécialisé en psycho-gériatrie au sein de Korian Belgium. Kinésithérapeute de formation et directeur de maison de retraite médicalisée depuis une dizaine d’années, il partage également ce qui l’a conduit à prendre la parole sur les réseaux sociaux : faire connaître les initiatives menées dans les établissements, valoriser le travail des équipes et donner davantage de visibilité à leur quotidien. 🎧 Bonne écoute ! Dominiek Beelen Luc Van Mellaert Lieve Van Boxem Dieter Opdecam Clariane

I’m looking for a small number of 𝐰𝐨𝐫𝐤𝐩𝐥𝐚𝐜𝐞 𝐰𝐞𝐥𝐥𝐛𝐞𝐢𝐧𝐠 𝐥𝐞𝐚𝐝𝐞𝐫𝐬 who are genuinely curious about what comes next. For the past two years, we’ve been supporting NHS staff with something very different from a conventional workplace wellbeing app. It’s called 𝐇𝐚𝐫𝐦𝐨𝐧𝐲 𝐅𝐥𝐨𝐰. Rather than simply providing content to watch or advice to read, Harmony Flow uses our proprietary 3xPureTone™ neuro-acoustic technology to help guide listeners towards specific states - including calm, focused attention, creative flow, recovery and sleep. The sessions were created to fit around the realities of a demanding working day: - A five-minute reset between meetings. - Support for sustained focus and productive work. - A proper mental break during a difficult shift. - Help switching off and recovering at the end of the day. Harmony Flow was originally developed around the needs of UK NHS (National Health Service) staff and has not previously been commercially available to the wider corporate market. We’re now preparing for the next stage. Before taking it further, I’d like to personally invite a small number of senior professionals responsible for workplace wellbeing, employee experience or people strategy to evaluate Harmony Flow for seven days. 𝐓𝐡𝐢𝐬 𝐢𝐬 𝐚 𝐩𝐫𝐢𝐯𝐚𝐭𝐞 𝐩𝐫𝐨𝐟𝐞𝐬𝐬𝐢𝐨𝐧𝐚𝐥 𝐞𝐯𝐚𝐥𝐮𝐚𝐭𝐢𝐨𝐧 - 𝐧𝐨𝐭 𝐚 𝐩𝐮𝐛𝐥𝐢𝐜 𝐟𝐫𝐞𝐞 𝐭𝐫𝐢𝐚𝐥. I’m not looking for hundreds of testers. I’m looking for thoughtful wellbeing leaders who understand the pressures of the modern workplace, are open to genuine innovation and can see the potential of technology designed to support both human wellbeing and performance. If that sounds like you - or someone you know - comment HARMONY below or send me a private message. I’ll review each request personally. ____ Mike Smith The future of workplace wellbeing is not more content. It’s technology designed to support how people feel. #WorkplaceWellbeing #WellbeingInnovation #Neuroacoustics #HumanPerformance #FutureOfWork

A question for business owners employing 50 people or more: what are you doing to help your team reset during the working day? Not another wellbeing document. Not another video telling people how to manage stress. Something they can actually use - in the moment - to support a calmer, more focused and productive state. For the past two years, we’ve been supporting NHS staff with Harmony Flow, a workplace wellbeing platform powered by our proprietary 3xPureTone™ neuro-acoustic technology. Its sessions are designed around the realities of demanding working days: - A five-minute reset between meetings. - Support for sustained focus and productive work. - A proper mental break when pressure is building. - Help switching off and recovering after work. As we prepare to introduce Harmony Flow to the wider corporate market, I’d like to invite a small number of business owners and Managing Directors to evaluate it personally for seven days. Try it during your own working day. Experience the technology for yourself. Then decide whether it may have value for the people working alongside you. This is a private professional evaluation - not a public free trial. If you own or lead a company with 50 or more employees and you’re genuinely interested in finding better ways to support your team, message me privately. I’ll review each request personally. ___ Mike Smith The future of workplace wellbeing should do more than inform people. It should help change how they feel. #WorkplaceWellbeing #BusinessLeadership #EmployeeWellbeing #Neuroacoustics #HumanPerformance

Good news. Ultrasound at Royal College of Obstetricians and Gynaecologists | RCOG . Experiencing an upcoming gamechanger within more specialties. Keywords are AI and Autra series. Thanks for having us SonoScape Europe and Kam Singh Small competition for danish collegues: what does the picture show? Answer closest to win a bottle of bubbles.

"Offertes schrijven...? No thanks!" Zo dacht ik erover, na mijn eerste ervaring in de wondere wereld van aanbestedingen... En toch kwam ik jaren later weer in een positie terecht, waarbij het mijn voornaamste taak is om offertes te schrijven! Waarom bevalt het me nu dan wél? 💙 Ik schrijf over de nieuwste snufjes van onze zorginnovaties, die bijdragen aan het oplossen van grote maatschappelijke problemen in de gezondheidszorg; 💙 Ik ben onderdeel van een hecht en fanatiek team, dat zichzelf keer op keer uitdaagt om onze boodschap vol enthousiasme over te brengen; 💙 Ik heb te maken met allerlei disciplines binnen de organisatie en leer dus élke dag bij! 💙 Het gaat natuurlijk veel verder dan alleen het schrijven van offertes... Samen met mijn team bedenk ik de winnende strategie om zo de klantfamilie verder te laten groeien! Last but definitely not least: ik krijg de ruimte om mijn werk op mijn manier te doen, om fouten te maken en daarvan te leren én om te proosten wanneer we weer een mooie mijlpaal bereikt hebben! Ook aan de slag als Tender Specialist Zorgtechnologie? Wees welkom bij CLB - Technology With Care! 💙 Beter zorg door innovatie 💙 https://lnkd.in/eac_x_er

Looking forward to the WELT AI Summit. What’s the next big thing ?

It’s official: Bayesian methods are acceptable, and moving beyond niche applications. The FDA’s long-awaited draft guidance issued earlier this year provides a clearer framework for applying Bayesian priors in confirmatory clinical trials. But, it seems, not all Bayesian priors are equal. The challenge for sponsors is not simply the selection of a prior distribution, but ensuring that historical information is scientifically credible. In my latest blog with Cytel, I explore the key elements needed to construct a scientifically defensible prior evidence package that will resonate with the FDA, from evidence quality and relevance to prior data conflict and alternative assumptions. Read the full blog now via the link below 👇 https://lnkd.in/e8nnsgW8