Healthcare innovation is in the heart of our co-founders’ DNA and our vision is to bridge the gap between idea and implementation by offering a Plug-and-Play quality management system (QMS) and acting as legal manufacturer of medical devices (including IVDs).
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.
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• is compliant with ISO 13485, MDD/MDR, IVDD/ IVDR and FDA standards
• is audited on a regular basis by customers and notified bodies
• is continuously improved to comply with regulatory updates and other improvements
• is freely configurable to your own needs and QMS scope
• Several companies (including ourselves) have passed notified body audits using the proposed QMS package
• We can provide support and training in the configuration or management of your QMS
• The QMS processes are easily understandable and clear.
• are responsible for Post Market Surveillance, Vigilance & Complaint Handling
• take care of supplier validation and audits
• Review and co-create the required documentation to facilitate compliance and obtain product (self-)certification
• keep all documentation needed to maintain product certification up to date
• Focus on innovation, product development and technical documentation
• Overcome the current shortage of Notified Bodies
• Retain full ownership of your intellectual property (IP) while benefiting from a streamlined path to market
• The QMS maintenance costs are shared between several companies – making outsourced LM a cost-effective solution
• Fast track certification solution by using (if possible) our notified body Technical Documentation sampling process
➡️ The Benefits of Outsourced Legal Manufacturing with Effectum Medical ⬅️
#1
We maintain a quality management system according to ISO standards for medical devices.
#2
We share the risk by acting as legal manufacturer for your product.
#3
We support you in maintaining your product registration (i.e. process validations, post market surveillance, etc.).
#4
We offer organizational structure & back office services, enabling you to focus on your core business.
ISO Certification
Product development
Product registration
Quality Management System (ISO)
Legal Manufacturer
Suppliers & manufacturers
Surgeons of different specialties
Scientific & technical experts
Project coaching
Set-up & planning of projects
Project management
Processes
Systems (profit center, QMS, PLM, contracts, etc.)
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.
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The Benefits of Outsourced Legal Manufacturing with Effectum Medical
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
Effectum Medical AG
Kirchgasse 11
CH-4600 Olten
+41 77 493 72 72
