ISO 13485 is a basic requirement for making medical devices available on the market in the EU. Compliance with the standard ensures the necessary quality and performance for the entire service life of the product.
Quality management at tuomi is based on ISO 13485:2016, taking into account IEC 60601, IEC 82304 and IEC 62304. This means that the work we carry out already meets the highest standards, allowing us to develop a wide range of software and hardware without changing the processes and workflows we already use.
You can benefit from our experience in the development of your quality management. Come and talk to us.
With our experience as a service provider for IoMT development we can help you turn your idea into reality. Using a gap analysis, we check your existing strategic concept for weaknesses. Then, working together with you, we will take the necessary steps to eliminate them.
In the case of medical products, this requires extensive knowledge of the Medical Device Regulation and the General Data Protection Regulation (GDPR). After all, the best idea is of no use if it cannot be implemented within the framework of the existing regulations.
A Proof of Concept will confirm how your idea can be transformed into a market-ready product. We have the experience to support you in this. Come and talk to us about how we can help.
The development of software and hardware for the medical sector not only requires technical know-how, but also an in-depth knowledge of the legal requirements. In every project patient safety is paramount, which is why the MDR imposes strict requirements on the development process and requires encrypted communication.
These legal requirements can change during the lifetime of your product so that your product will, in the course of time, have to meet ever more stringent security demands. With our forward-looking planning, you retain the flexibility to implement new requirements quickly, securely and without loss of function.
Talk to us today about your needs for tomorrow. We are happy to develop qualified individual solutions specifically for you and your project.
In Annex II, the MDR states: "documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of this Regulation and in particular the applicable general safety and performance requirements."
The verification checks whether the product complies with the legal requirements. The validation, on the other hand, focuses on whether the device fulfils its intended use and whether it is usable.
Verification and validation are thus decisive steps towards market readiness. As a certified service provider tuomi will plan the necessary tests and inspections with you.