The purpose of this IMDRF guidance is to harmonize the documentation and procedures that are 60 used to assess whether a medical device conforms to the regulations that apply in each jurisdiction. The worldwide adoption of fundamental design and manufacturing requirements for medical devices that, when met, provide assurance the device is safe and performs as intended, offers significant benefits to the manufacturer, user, patient or consumer, and to Regulatory Authorities. Eliminating differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments.
- Applying in parallel with an EU marketing authorisation application
- Notified bodies’ audits performed in the context of quality management system assessment
- FORMAÇÕES 2021 : CREDITAÇÕES PELA ORDEM DOS FARMACÊUTICOS.
- Calendário de formações 2021
- IMPLEMENTATION ROLLING PLAN Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Update dec 2020
- Register medical devices to place on the market
- 14ª Edição da formação sobre as BPD: “Uma revisão abrangente da temática ,que combina a legislação com casos práticos”
- Joint strategy sets direction for EMA and EU medicines regulatory agencies to 2025