The person responsible for regulatory compliance (PRRC) is responsible for ensuring that manufacturers and authorised representatives comply with the regulations.
Manufacturers must possess at least one PRRC in their organisation. A deputy PRRC must be defined and ensured, and the PRRC must suffer no disadvantage in relation to the proper fulfilment of their duties.
Authorised representatives must ensure that they have permanently and continuously at their disposal at least one person who possesses the requisite expertise as regards the requirements for medical devices specified in MedDO and who is responsible for regulatory compliance.

SERVICES:

• Assessment of the conformity of that device with the general safety and performance requirements.
• Drafting of Certificates of Conformity.
• Examination of legal requirements for the import and export of starting materials, packaging materials and medical devices.
• Interface to the regulatory authorities (Swissmedic).
• Ensuring the required quality of the manufactured medical devices.
• Review and approval of ISO relevant SOPs.
• Reviews of critical deviations and OOS.
• Handling of complaints and recalls.
• PRRC Deputy.
• Due Diligence Processes and Reports.
• Management of the electronic portals of Swissmedic and EU Authority.