Peercode is ISO13485-certified, and our medical devices are officially certified under Annex IX of the EU MDR. We would like to support you to achieve the same for your products.
Peercode can assist with setting up or improving your Quality Management System conform to the ISO13485 and/or the EU MDR requirements. ISO13485 is the internationally recognized standard for Quality Management Systems for medical-software and -devices. In addition, we offer consultancy on the topics of Medical Device Technical File and Design Dossier and on Investigational Medical Device Dossiers (IMDD).
We are experienced with Software as Medical devices and non-software related Medical Devices of all risk classifications.
Reach out to us to discuss how we can support your company.