Our electronic specialists support you during hardware development and verification activities.
The requirements for medical electrical devices and systems are more stringent than for other products due to the direct patient contact. The third edition of the IEC 60601-1 standard contains numerous changes, specifically alterations in electrical safety requirements for patients and operators (MOP). The coherence with risk management according to ISO 14971 requires a high degree of interdiciplinary project management. The third edition of IEC 60601-1 becomes effective with a transition period of three years (applicable is the point in time of the first placing into market) for CE-marking in Europe and FDA approval in the United States.
PROSYSTEM assists you during the design and development phase with specific knowledge transfer and guidance of your employees, and takes over project management responsibility.
Contact us for further details or a non binding quotation.