What you need know about electrical safety for medical devices according to the IEC 60601-series Electrical safety in medical devices is very important to ensure the safety of both patients and caregivers. The regulatory world of medical electrical devices can seem complex at times, especially with the transition to MDR and its new requirements. But, […]
Kom och lär känna oss på Key2Compliance på vårt nya kontor i Göteborg! Vi bjuder på en fullspäckad eftermiddag med värdefulla insikter, praktiska tips och framtidsspaningar. Flytten till GoCo house är en spännande expansion som sätter ännu en Key2Compliance-nål på kartan. Detta vill vi såklart fira tillsammans med dig! Vi bjuder på bubbel, snittar och […]
Usability evaluations for better safety and design of medical devices Usability evaluations are connected to the risk management and is an important part of the technical documentation. Performing formative and summative evaluations will make sure that the user of the medical device can use it safely. Usability evaluations are not only important for the sake […]
Internal audits – an opportunity to improve medical devices Internal audits are an important activity for medical device manufacturers. They are not only a requirement for ISO 13485 compliance, but also an opportunity to get valuable feedback that can help to improve both the medical device and the development process. Oscar He is coordinating the […]
Key2Compliance Coordinating manager for PRRC explains what you need to know about the new required role of Person Responsible for Regulatory Compliance The new medical device regulations MDR and IVDR have introduced a new role: Person Responsible for Regulatory Compliance (PRRC). According to Article 15 of MDR and IVDR, manufacturers of medical devices are now […]
