Effectum Medical facilitates an efficient, accelerated market access for MedTech innovators by offering a maintained Plug-and-play Quality Management System and when needed, acting as legal manufacturer. Our new Plug-and-play QMS is based on a modular concept where you can pick and choose the services that you require.
Not only Startups, but also R&D, Regulatory Affairs and Quality Management teams of established MedTech Companies can count on us as an external service provider.
Through Effectum CH-REP, a company of Effectum Medical, we give companies domiciled outside of Switzerland access to the Swiss market by acting as their Swiss Authorized representative.
 |
Plug-and-Play QMS Service Overview |
 |
Effectum CH-REP your Swiss Authorized Representative |
Through our team and network, we cover the entire value chain. You focus on your core competencies and we provide supply chain management as well as marketing, project management and back office services. Further more we enable direct access to financial partners and investors.
We can act as legal manufacturer of your product. Therefore, you do not have to go through the long process of building your own quality management system and you profit from lean product registration.
We are an experienced medtech team encompassing the necessary know-how and network of specialists to develop a successful business.
We are effective and efficient due to our experience and to leveraging existing organizational structures, including ISO certification.
#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
Marketing
Business development
Quality Management System (ISO)
Legal Manufacturer
Central back office services
Suppliers & manufacturers
Surgeons of different specialties
Scientific & technical experts
Financing partners
Project coaching
Set-up & planning of projects
Project management
Processes
Systems (profit center, QMS, PLM, contracts, etc.)
In spring, we completed our first IVD audit and our ISO 13485 certificate for In-Vitro Diagnostic products has now arrived! This has been the next important step for us to complete our service offering which now covers In-Vitro diagnostics in addition to Medical Device products and software. We are of course pleased to have received the certificate, but we are equally happy to have team members with a proven track record in diagnostics who can expertly accompany our customer projects.
This years POCDx Symposium will take place in Basel and Effectum Medical is honored to be a part of it. In addition to the main symposium there will be a pre-event held on October 19th where Effectum Medical will be speaking about IVDR Requirements for Diagnostic Products – in vitro tests, software, instruments
Registration is now open and you can benefit from early bird rates until August 31st, 2022.
For more details about the symposium and to register please visit the symposium website.
Effectum Medical AG
Kirchgasse 11
CH-4600 Olten
+41 77 493 72 72
