RAPS Nordic Local Networking Group

🎉 Congratulations to TÜV SÜD Denmark ApS on issuing their first CE mark under EU MDR (EU 2017/745)! This is a significant achievement, particularly for the Nordics, as the region has felt the impact of the shortage of Notified Bodies since the regulation’s implementation. TÜV SÜD’s success is a promising sign for smoother market access and compliance, supporting innovation and growth in the Nordic medical device industry. Well done, TÜV SÜD! 👏 #EUMDR #MedicalDevices #CEMark #NotifiedBody #Nordics

🌍 Exciting times ahead! The RAPS Convergence 2024 in Los Angeles is just around the corner, and we’re proud to share that our Chair, Jonas A. Bundgaard, along with one of the Country Leads for Norway, Alexey Shiryaev, will be representing the newly established RAPS Nordic Local Networking Group! 💼 This is a fantastic opportunity to connect with regulatory professionals from across the globe and strengthen our presence in both Europe and North America. 🌟 A big thank you to the Regulatory Affairs Professionals Society (RAPS) for organizing this incredible event! 🙌 Be sure to catch up with Jonas and Alexey in LA—let’s discuss challenges, opportunities, and how we can collaborate for a stronger regulatory future! 🚀 #RAPSConvergence #RAPS #Networking #RegulatoryAffairs

Dear all, The RAPS Nordic Local Networking Group (LNG) has returned from the summer holidays with yet another introduction from the leadership team for you! 🎉 Allow me to introduce myself as the Secondary Country Lead for Norway - Sara Edvardsen. An electronics engineer with a big heart for medical technology and an exciting attitude towards regulatory challenges 🚀. I am very excited that the time has come for gathering regulatory affairs professionals in the Nordics, so we can share experience and knowledge. Looking forward to intriguing, regulatory discussions and contributing to the future of health technologies, together with you all. Thank you to the Regulatory Affairs Professionals Society (RAPS) and Jonas A. Bundgaard for establishing the group and bringing me on board 🙏. Innovation of medical technology has been a huge interest of mine for the past eight years, ever since I started my M.Sc. in Electronic Systems Design & Innovation at Norwegian University of Science and Technology (NTNU) and went on with an additional specialisation in biomedical engineering at the University of Strathclyde in Scotland 🎓. As an engineer, I am overly excited about solving problems. I now work as a Research Scientist at St. Olavs hospital, Trondheim University Hospital, where solving problems results in improving patient care and saving lives. Few things are more inspiring than working at the hospital, witnessing how a medical device can have huge impact on a patient 👩⚕️. I also work nationally as a regulatory advisor in the Norwegian national partnership NorTrials, where I absolutely thrive with improving today’s patient’s access to tomorrow’s medical technology. My main focus is clinical investigation of medical devices; matching industry with suitable hospitals, and help teams plan and conduct studies in compliance with regulations and standards 📋. A local networking group for regulatory professionals in the Nordics is the perfect way to come together to solve challenges, and work towards even better patient care 🤝. We are inviting you all to join the RAPS Nordic Local Networking Group. Stay tuned – exciting events and opportunities are close by! 🌟 CC: Alexey Shiryaev / Mette Luxhøj / Ella Helgeman / Lucy Robertshaw, Jonas A. Bundgaard / Jens Schønberg / Mikko Soikkeli

📣 Attention all Nordic Regulatory Affairs Professionals! 📣 Join us at the first virtual event for the newly founded RAPS Nordic Local Networking Group (LNG)! This is a fantastic opportunity to connect, share insights, and collaborate with fellow regulatory experts in the Nordic region. We’ll introduce the LNG's objectives, activities, and the benefits of becoming a member of RAPS. 🗓️ Date: 29th of August 🕒 Time: 12.00 - 13.00 (CET) 📍 Virtual Event 💰 Free Admission Don’t miss out on this chance to expand your professional network! 🌍 Register now: https://lnkd.in/dvgGuiiK #RAPS #Networking #RegulatoryAffairs #RAPSNordicLNG #ProfessionalDevelopment

Hey everyone,   My name is Jens Schønberg and I am very happy to announce that I have been appointed Educational Lead for the newly established RAPS Nordic Local Networking Group (LNG)⭐. I am both excited and thankful to the Regulatory Affairs Professionals Society (RAPS) for this new opportunity to support the RAPS Nordic LNG with their events and educational opportunities going forward. It represents not just great new endeavors, but also some awesome problems to solve! I have an education as BSc. Electrical Engineering and master’s in software from DTU - Technical University of Denmark and started as an embedded Linux developer and have since moved into Cybersecurity 🛜. I’m currently working as a freelance Cybersecurity consultant and ever since being a teacher assistant in DTU many years ago, I have always loved educating/teaching. Currently, I also enjoy the opportunity to to teach and instruct at courses with Medicoindustrien in Denmark. Furthermore, I’m very involved with standardisation work within ISO - International Organization for Standardization and IEC (International Electrotechnical Commission) where i contribute to the development and revision of Cybersecurity standards. I am glad for this opportunity to invest myself in bettering education in the Regulatory Affairs space and hope to offer some perspective on especially software development, cybersecurity and technical aspects of medical device manufacturing as well as the evolving regulatory landscape within these domains. I look forward to collaborating with RAPS and the RAPS Nordic LNG to share some of what I personally think makes life-long learning great and learnable for anyone! 🧑🏫 Thanks to our chair Jonas A. Bundgaard and the rest of the leadership team at the RAPS Nordic LNG for this opportunity! CC: Mette Luxhøj, Jonas A. Bundgaard, Ella Helgeman MScEE, MBA,RAPS,TEAM PRRC,Lucy Robertshaw, Mikko Soikkeli, Kim A. Young

I am thrilled to announce that I have been appointed as Co-Chair and Country Lead for Sweden in the newly founded RAPS Nordic Local Networking Group (LNG) 🇸🇪 My name is Ella Helgeman, I have MsC EE and MBA and I am working as Regulatory and Quality Director at Rehaler in Copenhagen but I am based in Falsterbo Sweden. I am passionate about Medical Device Regulatory Affairs and have always enjoyed sharing knowledge and insights through conference speaking engagements and have been speaker at 20+ MedTech conferences. I started my professional career in the medical device industry 20 years ago having various positions including leadership positions in regulatory and quality at Nowwell, 3Shape, Merck Group, GN Group and ReSound to name a few. I have been working at Intertek Medical Notified Body AB (IMNB AB) as Regulatory and Quality Manager and I was Vice-Chair of NBTG Group (NBCG-Med technical group) while chairing Team NB Working Groups. Currently, I am TEAM-PRRC Country representative for Denmark and Sweden. Additionally, I am actively involved as a Chair and/or a member of few MedTech Europe working groups. This opportunity to serve within such a respected organization as the Regulatory Affairs Professionals Society (RAPS) is a tremendous honour. As Co-chair of the RAPS Nordic Local Networking Group LNG, I am excited to leverage my experience to further our mission of advancing the regulatory profession for Sweden as well as across the Nordics. I look forward to collaborating with colleagues and industry stakeholders to address the evolving challenges and opportunities in our field. Together, we will strive to share knowledge and support the growth of our community. Thank you to everyone who has supported me on this journey. I am eager to contribute to RAPS's mission and to make a meaningful impact in the regulatory landscape. We in the RAPS Nordic LNG leadership team are all excited about this new endeavour for the Regulatory Affairs Professionals Society (RAPS) in the Nordics and we warmly invite you to RAPS Nordic events, trainings and networking. I would like to express my gratitude to Jonas A. Bundgaard, the Chair of the RAPS Nordic Local Networking Group, for initiative and commitment to form and lead this new LNG. We extend an invitation for you to join our  RAPS Nordic Local Networking Group and stay tuned - there is so much good coming ⭐️   CC: Jonas A. Bundgaard, Lucy Robertshaw, Mikko Soikkeli, Mette Luxhøj, Ida Søholm, Jens Schønberg, Kim A. Young

Dear all, I am delighted to introduce myself as part of the leadership team, Co-Chair and the Country Lead for Denmark for the new RAPS Nordic Local Networking Group. My name is Mette Luxhøj and I am based in Copenhagen. My heart started beating for Regulatory Affairs and medical devices when I joined Lægemiddelstyrelsen (Danish Medicines Agency) more than a decade ago. I continued my journey as a regulatory professional in industry and stepped into various leadership roles in Radiometer Medical, Danaher, (MD/IVD/SaMD). Chairing the Software Task Force in MedTech Europe and represented industry in MDCG. Currently I am Director and Head of Regulatory Affairs, Software (Digital Health and Advocacy) in 3Shape. I am also Vice President in ADDI and representing the dental trade association FIDE in the EU Commission, MDCG, on New Technologies and International Matters. In Medtech Denmark, Medicoindustrien, I am Chair of the AI Task Force focusing on the interplay between the AI Act and MDR/IVDR. I am overall very engaged in networking, knowledge sharing, harmonization and enabling regulatory pathways and look so much forward to getting started on this RAPS journey. In my spare time I enjoy travelling, hiking and hot yoga. I am also a big wine and oysters’ enthusiast and hope these two elements can be combined with future networking sessions in this forum 🥂 In the leadership team, we are all super excited about this new endeavor for the Regulatory Affairs Professionals Society (RAPS) in the Nordics and we can’t wait to invite you for events, trainings and networking. I would like to convey a big thanks to Jonas A. Bundgaard Bundgaard, Chairing the RAPS Nordic Local Networking Group for all his efforts on the initiative and representing us at RAPS Euro Convergence in Berlin last week. Please join us in the RAPS Nordic Local Networking Group and stay tuned - there is so much good coming❣️  

🌟 RAPS Euro Convergence is just around the corner, so come say hello at our table! Let’s chat about future events and discuss how we can support you in our common endeavor to make a positive impact on the regulatory landscape! 🌏

Hello All RA professionals!   My name is Mikko Soikkeli and as part of the leadership team presentation, I’m happy to introduce myself as the Country Lead for Finland in the RAPS Nordic Local Networking Group. I also act as a co-chair together with the rest of the leadership team, led by chair Jonas A. Bundgaard.   My work life started in a QA position in a pharmaceutical company developing DNA vaccines. I have to confess that when starting, I was actually more interested in R&D, but quickly understood the importance and beauty of quality and regulations. Since then, I’ve been on that path in start-up companies and large multinational corporations in roles related to QA, RA, auditing, notified body, medical devices and IVDs.    Nowadays I work for Sertio Oy as a CEO and deputy head of notified body. Sertio Oy is a notified body under the IVDR (EU)2017/746 and is performing conformity assessment for IVD medical device manufacturers globally.    I’m an enthusiastic outdoor person and enjoy jogging, forestry work, hiking and snowboarding.   Looking forward to connecting and interacting with you within the Regulatory Affairs Professionals Society (RAPS) community!!

Hello everyone, I would like to introduce myself as the Country Lead for Sweden within the RAPS Nordic Local Networking Group! My name is Lucy Robertshaw and I started my career when I was 16 years old working in a Medical Centre with 12 doctors and 16,000 patients where I was trained as a medical receptionist and administrator, there I got the opportunity to do my business management degree and from that time I care passionately about us all having the best healthcare service we can. Since then, I have worked within life sciences, I have had my own company for 14 years, but I realised that to learn more about Regulatory Affairs I need to join a company that would give me training on the job. Today I work at TR Equipment, we are a class 1 medical product manufacturer based in Tranäs, Sweden, we are ISO 9001 compliant with a desire to be ISO 13485 compliant, so we are now starting this journey. We also had an FDA audit during December for 4 days which was a great experience to get ready for this but also to be thrown in at the deep end and learn on the job. Outside of work, I love spending time with my best friend Blixten who is a 26-year-old horse, he has taught me a lot about being in the here and now plus also to take time enjoying Swedish nature. I invite you to join us at the RAPS Nordic Local Networking Group to expand our knowledge, build valuable connections, and shape the future of regulatory affairs. I'm looking forward to our upcoming events, starting with our first virtual gathering. This event is a unique opportunity for you to help shape our future sessions and networking activities. Stay tuned—this is your RAPS Nordic LNG!