Congenius AG

📢 Our October #medtech news is now ready to read! Making the roundup this month: 📰 The EU Parliament resolution on #MDR revision 📰 MDCG guidance on IVD qualification and legacy devices respectively 📰 The next #swissdamed deadline 📰 FDA updates related to its Safety & Performance Based Pathway, recent #biocompatibility draft guidance, and a useful #digitalhealth and AI glossary 📰 News from China's NMPA on overseas on-site inspections and new industry standards Read the full bulletin below 👇 https://lnkd.in/dxEf-PcW #medicaldevices #regulatoryaffairs

Great event today at Digital Health Day organized by Swiss Healthcare Startups - looking forward to the sessions to come and interesting talks during the day!

📢 Introducing our Congenius "5-minute guides": providing quick, digestible summaries of timely topics related to #medtech and #medicaldevices... Our first guide is brought to you by our Head of Operations Marc Friedli on the subject of #pfas in medical devices 🧪 Per- and polyfluoroalkyl substances (PFAS) are set to be increasingly regulated in the EU. Below, Marc walks through defining PFAS, the EU regulations and the reasons behind them, and a top line action plan for manufacturers of medical devices in the EU... And should you have a PFAS in medical devices related challenge, do get in touch 📧 👉 https://lnkd.in/d6bddhsp

Today was another great and informative day at the National Regulatory Congress in Bern perfectly organized by Swiss Medtech. The event is always a great opportunity to get up to date with the latest regulations in the medical technology sector and to maintain the personal network. This year we as Congenius AG in close cooperation with ISS AG, Integrated Scientific Services(Bernhard Bichsel), Sidley Austin LLP (Eva von Mühlenen, LL.M.) and The Tao of Excellence (Jasminka Roth) were able to participate in the organization of 2 breakout sessions on the topic of digital medical products and their regulatory implications - 2 sessions with very instructive and topical presentations and excellent moderations on these topics. A big thank goes to: Richard Etter Dominik Guenzel Julian Selz Daniel Ziegelmayer Carlo Gherardi Michael Renaudin Stephan Martin Lendi Bettina Knellwolf Daniel Delfosse

Greetings from the Swiss Medtech National Regulatory Conference 2024! Our CEO Bastian Perroset, Founder and Executive Board Member Joerg Dogwiler, and Head of Regulatory & Clinical Bruno Gretler are delighted to be attending the event today. We’re especially looking forward to this morning’s Digital Breakout Session, with engaging presentations planned from Richard Etter, Dominik Guenzel, Julian Selz, and Daniel Ziegelmayer. Spanning commercialisation, business models, EU & US #regulatory frameworks, and #cybersecurity for digital products, the session promises to be informative and insightful! #medicaldevices #consultancy #regulatoryaffairs

Who will be joining us for a journey of #biocompatibility discovery next week? 🙋♀️ 🙋♂️ There's still time to register 👇 https://lnkd.in/dsK8knXF Dr Silvio Peng - we're looking forward to your insightful session!

🎉 This month we warmly welcome Marco Bühlmann as the newest addition to Team #operations Joining us as an Operations Consultant, Marco will be providing project support as a Production Technology Engineer. Marco holds an advanced degree in mechanical engineering with a focus on energy technology, and has completed lengthy tenures at renowned industrial equipment and professional product firms. Having held several leadership roles in mechanical development and validation, he brings with him a wealth of knowledge in this field. Welcome Marco, we’re delighted to have you on board! #team #medicaldevices #consultancy

We’re looking forward to the Swiss Medtech National Regulatory Conference next week! This year, in close collaboration with ISS AG, Integrated Scientific Services, Sidley Austin LLP, and The Tao of Excellence, we’ve organised three topical presentations for the morning Digital Breakout Session. Covering commercialisation, business models, EU & US regulatory frameworks, and #cybersecurity for digital products, the presentations will be brought to life by our esteemed colleagues: 🎤 Richard Etter – Managing Director at Oviva 🎤 Dominik Guenzel – Senior Europe Business Development Manager at Lunit Cancer Screening 🎤 Julian Selz – Senior Market Development Manager for Surgical Innovations at Medtronic, and 🎤 Daniel Ziegelmayer – COO at mdeg - Medical Device Engineering Group With the session expertly moderated by our partner Stephan Martin Lendi See you there! #medicaldevices #regulatoryaffairs #digitalhealth #consultancy

Medical devices containing #artificialintelligence or #machinelearning still pose significant challenges for #regulatory authorities and manufacturers alike, due to several unknowns about AI and its behaviour, and a lack of solutions for how to fulfil certain regulatory requirements. In our latest topical article, our Head of eHealth Dr Dirk Hueber shares 5 practical tips for how manufacturers of #medicaldevices that contain AI can fill, or at least mitigate, some of these knowledge gaps. Find out more at the link below 👇 https://lnkd.in/dcsjVa3N

We were delighted to lead this month's #medtech talk at Sitem StartUp Club (SSC) earlier this week on the topic of #riskmanagement. A big thank you to Geghetsik Gabrielyan and team for the great organisation, and also to those who attended the session - we thoroughly enjoyed connecting with you and exchanging ideas! #partnership #startups #medicaldevices