The MDR presents new challenges to medical device manufacturers: How should they map PMS? Which solutions support risk management? With Teamcenter, the PLM system that connects people and processes, the medical device manufacturer Julius Zorn has found a solution.
New challenges demand new solutions
MDR brings some changes to the processes of Julius Zorn GmbH (JUZO) in Aichach (D). JUZO develops medical aids that accompany patients from the beginning to the end of their therapy. The company concentrates on the following four areas: Vein therapy, edema therapy, scar treatment, and orthosis/bandage.
Due to the new MDR guidelines, Post Market Surveillance (PMS) has become an essential topic for JUZO. But also the Unique Device Identification (UDI) becomes necessary up to Medical Class I.
Julius Zorn found a solution to master these new challenges with Teamcenter's Medical Device Solution, the adaptable Product Lifecycle Management (PLM) system from Siemens.
The implementation of Teamcenter PLM is planned, accompanied and carried out by the Siemens Smart Expert Partner avasis GmbH, CH-Berneck and D-Radolfzell. The Medical Device Solution supports the users with a phase/gate based DHF. Depending on the type of development, different templates can be used to create a suitable DHF structure and fill it with document templates. The DMR or TF is derived from this DHF and transferred to a DHR in the design transfer. Concerning the MDR, Teamcenter will also support the processes of Julius Zorn GmbH with the Medical Device Solution for topics such as PMS, UDI, etc. in the future.
The results of the customer
The largely paper-based documentation of processes, the partly manual communication and also the manual control of documents has been raised to a new level: By establishing a quality standard in the documentation as well as clear responsibilities and designated persons in charge, the coordination of the individual departments and responsibilities has been sustainably improved become.
Thanks to seamless documentation, automatic linking of information and a comprehensible approach, risk management was adapted to the needs of MDR. The Teamcenter Medical Device Solution supports these processes and ensures relations as well as traceability.
With the help of the Phase / Gate DHF (Design History File) implemented in Teamcenter Medical Device Solution, a guide has been developed to systematically guide users through the development process. Decisions are traceable, the relationships of the individual documentations with each other are visible and comprehensible. Everyone in the company knows where to find the information.
The previous methodology in the documentation process was mostly paper-based. JUZO now relies on content-controlled reports and digital documents. The procedure was previously QM manual driven with many media breaks. With the Medical Device Solution, JUZO can now use end-to-end processes and system-driven workflows to reduce the time it takes to familiarize employees with training.
The data was previously held in the file system in so-called data silos or island solutions, printed on paper and submitted to the notified body. With PLM (Product Lifecycle Management) JUZO can now access the clear, valid data worldwide. The access is controlled controlled, so that each user can work with all data to which he is entitled. The change process is anchored in the system, ensuring consistent information. With PLM, users have the right information, at the right time, in the right place for the right person.
The advantages of the customer
The advantages that JUZO has gained with the introduction of the Teamcenter Medical Device Solution are:
- Optimization of own processes
- Support of post market surveillance through schedule management
- Benefits of new digital media
- Avoid duplicates; Multiple use is controlled and traceable
- Simplification and standardization of documentation
Julius Zorn GmbH continues to progress purposefully along the path of digitization, thereby securing valuable advantages in terms of time, quality and thus also monetary aspects.