The goal of this workshop is to give an overview of the regulatory landscape for medical devices in Europe (MDR/IVDR) and to touch upon different aspects for USA. You will get a good understanding of the product development process, as well as the requirements regarding technical documentation. The shared insights help you to early identify the key topics of your project to be successful mid and long-term.
The new IVDR, coming into force on May 2022, will have major implications on your operations. The need of a notified body for app. 80% of products, even for existing ones, and the assignment of a Person Responsible for Regulatory Compliance (PRRC) are only some of them. READ MORE
We support innovators in realizing their ideas, establishing sustainable businesses and to reach a successful exit. We provide an outsourced Quality Management System which our customers use to document their development, and market their Medical Devices.
Offering all needed competencies, we can act as legal manufacturer and provide our clients with a lean product registration as well as engineering services. For each project phase we offer a variety of matching services.
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.
We Care For Your Idea!
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.)
Effectum Medical AG
Solothurnerstrasse 235
CH-4600 Olten
+41 77 493 72 72
