Congenius AG

It’s often said that the number 8 symbolises a continuous journey and enduring connection. As we navigated 2024, 8 years after the founding of Congenius, we were fortunate to achieve several exciting milestones along the way - from reinforcing our customer relationships and forging new #partnerships, to welcoming team members, launching products, and ushering in a fresh chapter with our new CEO.   These successes would not have been possible without the lasting support and #collaboration from our customers, partners, and #team. So, as the year draws to a close, we’d like to extend a heartfelt #thanks to our valued network!   We’ve wrapped up some highlights below to celebrate a fantastic 12 months. And as we raise a glass in appreciation, we look ahead to 2025 with optimism and excitement for what comes next.   Wishing everyone a season of infinite joy and a happy & healthy new year!   #medicaldevices #consulting

🎄 What a great way to usher in the holiday spirit with the Congenius #team last night! Following a welcome apero hosted by our CEO Bastian Perroset, we enjoyed a few fun rounds of Eisstockschiessen before sharing a delicious fondue dinner together 🫕 A lovely evening spent celebrating the team’s hard work this year, and a nice opportunity to catch up with the Congenius alumni. Thanks to all who made the journey to Aarau to join in with the festivities! 🥂🎁

We’re delighted to welcome Dr. Martina Hersberger, PhD to the Congenius #team! Joining us as a Clinical Affairs Consultant, Martina is the newest addition to our #clinical department, and will be providing project support as a Clinical Scientist. Martina brings with her a Master of Science in Molecular and Cellular Biology from the University of Zurich, and several years of experience as a Lab Manager and Research Technician at the institution. After completing her PhD studies, she moved into the #medicaldevice industry as a Clinical Project Junior Lead in 2022, before being promoted to Clinical Project Lead last year. Welcome Martina! #consultancy #medicaldevices

A big thank you to our colleague, Industry Expert & Digital Shaper Philipp Schmid for delivering an engaging Late Afternoon Talk to our Congenius team yesterday evening! During the 60 minute webinar, Philipp outlined where #AI technology in #manufacturing and operations stands today, discussed some of the stumbling blocks, and shared concrete examples to show the enormous potential of #artificialintelligence in industry. Many thanks again Philipp! 🙏 For more on AI related to the #medicaldevice industry, take a look at our recent whitepaper via the link below 👇 https://lnkd.in/dcsjVa3N

Just 10 days to go until our next Congenius Academy webinar! Don't miss the chance to brush up on some #regulatory basics for #medicaldevices with our Head of Regulatory Bruno Gretler and Senior Regulatory Consultant Ima Miermeister - register your place below 👇

A warm welcome to Congenius, René Mathys! We’re delighted to announce that René has joined our Quality #team this month as a Senior Consultant in Device Development. René brings with him a strong academic background, holding an MSc. in Mechanical Engineering from ETH Zürich, as well as diverse experience gained at prominent Swiss and global #medicaldevice firms. Whilst undertaking roles in leadership, management, and engineering, René developed his knowledge of the #medicaldevices field working on computer-assisted surgery, spinal orthopaedics, and insulin pumps. In 2019, with a passion for driving innovation and improving healthcare outcomes, René began his chapter as a CTO, leading and managing a technology department and playing a pivotal role in quadrupling his organisation’s workforce. Welcome on board René! #consultancy #quality

📰 Our November #medtech news is now available! Making the roundup this month: > MedTech Europe’s recommendations for #eugreendeal implementation > MDCG guidance on the #regulatory status of Ethylene Oxide (EtO) > Q&As on gradual EUDAMED roll-out and #medicaldevice supply interruption & discontinuation > A questionnaire from Team NB on #artificialintelligence in #medicaldevices > Guidance from Swissmedic on clinical investigations, performance studies, and combined studies > FDA guidance on EtO sterilization facility changes for Class III devices > Final FDA guidance for orthopaedic non-spinal bone plates, screws, and washers > A whitepaper on software bill of materials (SBOM) from MITRE For all this and more, read the full bulletin at the link below 👇 https://lnkd.in/dUx4Cjnc

We’re very happy to share that Claude Denier joined our growing #team this month! Claude is the newest addition to Team Operations, bringing with him an MSc. in Material Sciences from ETH Zürich, and extensive R&D knowledge gained during tenures at both academic and industry organisations. Claude's experience spans roles in research, project management, production, and leadership, specialising in polymer nanotechnology, the industrial production of micro-structured polymer parts, and sustainability. In 2021, Claude embraced his entrepreneurial spirit, and embarked on a journey of self-employment, leading and managing R&D projects for a variety of customers, whilst simultaneously developing and distributing his own sustainable raw materials. Welcome Claude, great to have you on board! #medicaldevices #consultancy

📢 Registration is now open for our next Congenius Academy webinar! Demystify the path to market by joining our Head of Regulatory Bruno Gretler for a 60 minute walk-through of the #regulatory basics for marketing #medicaldevices. The session aims to equip participants with the foundational knowledge needed to navigate the regulatory landscapes of the EU and US: ⏰ 11:00 - 12:00 CEST 📅 Friday 13 December 💻 Online Secure your place at the link below 👇 https://lnkd.in/de7cixGX #medtech #training

📢 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