Quality Assurance Support for Your Medical Device
The regulatory framework for medical devices includes standards that establish requirements for quality management systems applicable to every manufacturer. Although these requirements are universal, the implementation can vary depending on several factors, such as device type, risk classification, etc. Building and maintaining a quality management system (QMS) requires a comprehensive approach and can be challenging. An effective QMS fulfills regulatory requirements and ensures the development and production of safe and effective medical devices.
Quality assurance encompasses many elements, including manufacturing, supplier management, vigilance and complaints handling, risk management, and the activities of the person responsible for regulatory compliance (PRRC). These elements are crucial and must be adequately supported within the QMS.
What can we do for you?
Our experienced medical device team can support you with quality assurance services
- Mock audit for ISO 13485
- QMS consulting
- Mock audit for MDSAP
- Medical device manufacturing support
- Medical device supplier support
- Medical device vigilance and complaints handling
- Risk management according to ISO 14971
- PRRC