A straightforward overview with a practical example
The white paper provides a straightforward illustration and description of the UDI System, based on a practical example.
The new EU-Regulation for medical devices (MDR) requires a unique product identification and the adherence to registration regulation.
The UDI code shall be publicly available through registration in a central database. The requirement for UDI is new and the central database is not yet available. Therefore, no practical examples and experiences are available. However, medical device manufacturers must find a way to prepare for the implementation of the UDI system.
Bringing your project to success while mastering the challenges of MDR/IVDR, 19. November, 2019 (Olten)
Which steps do I have to take for development and industrialization of my product? How do I document appropriately and how can I ensure to get certification? These are the ultimate questions for anyone developing a new product. If these are the challenges you are facing, this workshop session will help you to master them.
The objective of our new workshop is to understand the product development process for medical devices as well as the regulatory requirements regarding documentation. You will get an overview of the product development process and documentation, combined with hands-on experience from real case examples.
If you are manager or team member in a start-up or spin-off, this workshop is for you! For more information on this complimentary workshop and how to register, please click here.
We accelerate innovation in the Medtech & Healthcare industry and bring them successfully to market. As a center of excellence for the entire innovation process we reduce costs, shorten time-to-market, increase chances for market success and reduce risks for investors.
Providing all needed competencies and an own quality management system, we can act as legal manufacturer and provide our clients with a lean product registration as well as marketing and back office services.
Effectum Medical creates innovative, new products and companies.
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 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.
We maintain a quality management system according to ISO standards for medical devices.
We share the risk by acting as legal manufacturer for your product.
We support you in maintaining your product registration (i.e. process validations, post market surveillance, etc.).
We offer organizational structure & back office services, enabling you to focus on your core business.
Quality Management System (ISO)
Central back office services:
Financing of ventures
Suppliers & manufacturers
Surgeons of different specialties
Scientific & technical experts
Set-up & planning of projects
Systems (profit center, QMS, PLM, contracts, etc.)
Effectum Medical AG
+41 62 211 63 06