Archive
02. April 2025
Unlocking Growth for Startups:
The Benefits of Outsourced Legal Manufacturing with Effectum Medical
MedTech startups often face complex regulatory hurdles and high costs. Our new White Paper reveals how outsourcing Legal Manufacturing to Effectum Medical helps overcome these challenges: Faster market entry, reduced costs, and lower risks – all while maintaining full control over your intellectual property.
Discover how partnering with a certified expert can bring your innovation to market efficiently.
Download now and gain a competitive edge!
The Benefits of Outsourced Legal Manufacturing with Effectum Medical
17. March 2025
PRESS RELEASE
Healthcare Holding Schweiz Acquires
Effectum CH-Rep AG (Switzerland)
Healthcare Holding Schweiz AG, a leading service provider and distributor of medical devices in Switzerland, is expanding its portfolio with the acquisition of Effectum CH-Rep AG. Healthcare Holding Schweiz is managed by Winterberg Advisory GmbH.
Olten, Switzerland – March 2025
Healthcare Holding Schweiz AG has successfully completed the acquisition of Effectum CH-Rep AG. This transaction marks a carve-out of all services provided as Swiss Authorized Representative (CH-REP) from Effectum Medical AG. Under the Medical Devices Ordinance (MedDO SR 812.213) effective since May 26, 2021, manufacturers of medical devices without a registered office in Switzerland must appoint a CH-REP to distribute their products within the country. Through this acquisition, Healthcare Holding Schweiz AG strengthens its position as a comprehensive partner for medical technology manufacturers worldwide. With its group of companies, it can now provide integrated services that encompass not only import and distribution but also full compliance with regulatory requirements.
Fabio Fagagnini, CEO of Healthcare Holding Schweiz, expressed his enthusiasm for the acquisition: “With Effectum CH-Rep, we are expanding our service portfolio to include the role of Swiss Authorized Representative, thereby strengthening our growing group. This allows our sales representatives and managing directors to focus even more on innovative products and exceptional customer service, with the assurance that all regulatory requirements are being professionally met.”
Kim Züger, Head of Quality Management & Regulatory Affairs and the newly appointed Director of Effectum CH-Rep, emphasized: “Regulatory compliance is our top priority. Through Effectum CH-Rep, we offer this service not only to suppliers of Healthcare Holding Schweiz but also to numerous other manufacturers — a clear testament to our professionalism and high-quality standards.”
Michael Eggimann, Board Member of Effectum Medical AG and responsible for the sale of Effectum CH-Rep AG, added: “We have valued working with Fabio Fagagnini and his team for many years and are confident that Effectum CH-Rep is in excellent hands. This transition allows us to fully concentrate on the further development and distribution of our Legal Manufacturing offering as well as our innovative plug-and-play quality management system, while continuing to collaborate closely with Effectum CH-Rep for the benefit of our customers.”
About Effectum CH-Rep AG
Effectum CH-Rep AG, based in Olten, facilitates access for foreign manufacturers of medical devices to the Swiss market by acting as the Swiss Authorized Representative (CH-REP). As a CH-REP, Effectum CH-Rep AG takes on responsibilities such as ensuring compliance with Swiss registration requirements, collaborating with Swissmedic on preventive and corrective actions, providing a Person Responsible for Regulatory Compliance (PRRC), guaranteeing access to technical documentation, and reporting incidents and complaints.
About Effectum Medical AG
Effectum Medical AG, based in Olten, is a manufacturer of medical devices (incl. IVDs) and a Quality Management and Regulatory Affairs consulting service. The aim is to promote healthcare innovation by offering legal manufacturing as a service and by also offering a Plug-and-Play quality management system (QMS) for companies wishing to setup or improve their own QMS for medical devices/IVD. The Effectum Medical team unites hands-on MedTech business and management experience with in-depth knowledge of regulatory affairs and quality management for medical devices, medical software and in-vitro diagnostic products. In addition, we provide access to a unique network of experts along the entire value chain.
About Healthcare Holding Schweiz AG
Healthcare Holding Schweiz AG is a Buy, Build & Technologize platform and a leading provider of medical technology products and services in Switzerland. The group is based in Baar and pursues an ambitious growth strategy through acquisitions, often in the context of succession arrangements, partnerships, and organic growth. Healthcare Holding Schweiz and its group companies are committed to the highest standards of innovation and customer satisfaction. The group consistently leverages technology to make business processes safer and more efficient. As a market leader, the company sets new standards for the industry and offers employees attractive development opportunities. All of the management team holds shares in Healthcare Holding Schweiz, thus forming a dynamic community of entrepreneurs.
About Winterberg Advisory GmbH and Winterberg Group AG
Winterberg Group AG, based in Zug, operates as an independent family office for its founders. Winterberg mainly invests in SMEs in the German-speaking region, and selectively considers investments in startups and real estate. Winterberg Advisory GmbH is a general partner and fund manager regulated by the German BaFin. Winterberg Advisory has launched numerous private equity funds and is invested in Healthcare Holding Schweiz AG through its funds Winterberg Investment VIII and Winterberg Investment IX. The two Partners and Executive Directors, Fabian Kröher and Florian Brickenstein, manage Healthcare Holding Schweiz AG via its board of directors.
For more information about Effectum CH REP AG, visit www.effectum-chrep.com
For more information about Effectum Medical AG, visit www.effectummedical.com
For more information about Healthcare Holding Schweiz AG, visit www.healthcare-holding.ch
This press release is issued and distributed by Effectum Medical AG
10. February 2025
New report alert: Unlock the €498bn German healthcare market
We had the opportunity to review the latest report from EIT Health, and we’re proud to have contributed to this important work. Thank you to EIT Health for trusting us with this task. It’s been great to support such a valuable initiative that drives innovation and progress in healthcare across Europe.
EIT Health is proud to launch “MedTech and Digital Health: A Comprehensive Guide to Market Access in Germany”. This essential guide offers European healthcare start-ups actionable insights to navigate Germany’s complex regulatory landscape and seize opportunities in Europe’s largest healthcare market.
What’s inside?
Tips for regulatory success, including MDR & CE certification.
A guide to Germany’s reimbursement pathways (DiGA, SHI, PHI).
Proven market entry strategies, drawn from real-world success stories.
Whether you’re just starting out or planning to expand, this guide equips you to unlock Europe’s largest healthcare market.
Download it now and accelerate your market entry: https://loom.ly/Nse1-fM
Stay tuned for more reports to empower your MedTech and digital health journey across Europe.
05. December 2024
QMS Plug & Play Bootcamp Spring 2025
Are you a medical device start-up and the topic of quality management system (QMS) gives you more stress than pleasure? Do you associate with QMS a lot of work that is not really part of your core competence but a necessary evil of your venture?
Then this workshop is just right for you. In our modular and hybrid bootcamp, you will acquire an ISO 13485 QMS, which is continuously maintained and can be adapted to your needs.
Curious? Then contact us for more information and save your early bird ticket before January 31st, 2025.
Attention: New Deadline!
The new registration deadline is February 14, 2025.
2025-Plug-Play-QMS-Bootcamp-Effectum-Medical_V2.pdf
26. November 2024
CE-Certified Smartphone Blood Pressure Monitoring by Swiss Company Biospectal
Case Study Biospectal
Swiss start-up Biospectal has introduced OptiBP™, an innovative smartphone app for blood pressure monitoring. Users can measure their blood pressure quickly and conveniently in just 30 seconds by placing their fingertip on the smartphone camera. Developed in collaboration with the Swiss innovation hub CSEM, the technology uses optical biosensing and AI algorithms and meets the strict CE EU-MDR certification standards.
Key Benefits of the App:
- Accurate, user-friendly blood pressure monitoring anytime, anywhere.
- Quick and easy sharing of results with doctors and family members.
- Avoids stress-related inaccuracies caused by the “white coat syndrome.”
Background:
Hypertension affects 1.3 billion people globally and is a leading contributor to heart disease, the most common cause of death worldwide. The app aims to improve early detection and management, reducing health and economic burdens. According to WHO, targeted hypertension management programs are among the most cost-effective healthcare measures.
Technology and Development:
OptiBP is based on over 15 years of research and more than two million clinical measurements. Its accuracy has been validated globally in studies conducted in Switzerland, Belgium, and low-resource settings, with support from organizations like the Bill and Melinda Gates Foundation.
Future Plans:
Following its launch in Switzerland, Biospectal plans to expand to other European and global markets.
Founded in 2017 and headquartered in Lausanne, Biospectal aims to revolutionize blood pressure monitoring. CSEM, a key partner in the technology’s development, is a renowned innovation center focused on creating impactful technologies for society.
24. May 2024
Listed as a Top 9 Medical Device Consulting Firm of 2024 by Qualio!
We are delighted to have been listed as one of the 9 top medical device consulting firms of 2024. You can find the article here
Contact us to learn more about Effectum’s activities and how we can support you as legal manufacturer of your product, as consultants or in setting up your own QMS with our SOP packages.
06. May 2024
Next Plug & Play Bootcamp – Autumn 2024
We are happy to announce the completion of our second QMS Bootcamp with excellent participants and discussions! Thank you and well done to all!
The buzz surrounding our next Bootcamp this Autumn is growing. Now is the perfect time to seize this opportunity and equip yourself and your team with the knowledge and skills needed to navigate the complexities of quality assurance in combination with our proven Plug&Play SOP Packages.
Whether you’re a seasoned professional or new to the field, our Bootcamp offers a comprehensive learning experience tailored to meet the demands of today’s regulatory environment. The bootcamp helps all companies wishing to setup their own Quality Management System and gives you a kick-start when it comes to implementing and configuring the processes to your needs.
Join us this Autumn for our next Plug & Play QMS Bootcamp and take the next step toward ensuring a compliant QMS and the safety
All dates and more information can be found here:
2024-Autumn_Plug-Play-Bootcamp-Effectum-Medical_V1.pdf
05. March 2024
Discover our two podcast episodes with Karina and Nila!
In the first podcast interview with Karina Candrian, you will find out how an impressive company growth of 400% was possible in just a few years. Also find out how our ‘Priority Board’ helps to manage internal processes and how we establish and maintain our company culture.
Spotify: https://lnkd.in/e2CxRMuw
Apple: https://lnkd.in/gXFE2CDF
Google: https://lnkd.in/gp7cRhSi
In the second podcast with Nila-Pia Rähle, it’s all about the ‘healthcare marketplace’. Nila shares insights on how she supports start-ups in getting their products approved and shows ways to bring them to market faster.
Website: www.gesundheitswesen.org
Spotify: https://lnkd.in/etEWtdPi
Apple Podcasts: https://lnkd.in/eHdd6ryF
Soundcloud: https://lnkd.in/eUUDrk6R
19. February 2024
Joint lunch session with Evolution Europe
Accelerate your innovation journey: A (public) funding guide for Swiss start-ups.
In a joint session with Noemí Quesad, Business Development Manager at Evolution Europe, a guide to public funding for Swiss start-ups will be presented. Learn how to accelerate your innovation journey and gain insights into the funding opportunities available for Swiss start-. Join us to gain valuable information and take your start-up to the next level.
📅 March 11, 2024
⏱️ 12-13h
🌐 Online event
Register now for the free lunchtime event and gain insights into financing opportunities for Swiss start-ups.
12. December 2023
Plug & Play (e)QMS Bootcamp – Spring 2024
Are you a medical device start-up and the topic of quality management system (QMS) gives you more stress than pleasure? Do you associate with QMS a lot of work that is not really part of your core competence but a necessary evil of your venture?
Then this workshop is just right for you. In our modular and hybrid bootcamp, you will acquire an ISO 13485 QMS, which is continuously maintained and can be adapted to your needs.
Curious? Then contact us for more information and save your early bird ticket before January 31st, 2024.
2024-Plug-Play-Bootcamp-Effectum-Medical.pdf
