This service is for EIC beneficiaries that are moving from the discovery/design phase into development, and requiring the implementation of a QMS system and compiling of technical documentation for product submission. A range of activities related to operational QA/RA are covered by this service. 

Typical activities include: 1) Implementation of COVARTIM’s in-house APEX QMS: Through workshops, process by process, that capture the manufacturer’s current way of working and aligning to the requirements of ISO 13485. Once the transfer of the documents is completed, COVARTIM sets up and deploys the quality system. Should the manufacturer appoint a Quality Manager outside of COVARTIM, then support and training is provided to the appointed person. After several months of use of the quality system, an internal audit is conducted to ensure that the system is well maintained and ready to be certified. 2) Regulatory gap analysis: COVARTIM conducts a gap analysis for the selected product, comparing all existing data with requirements outlined in MDR 2017/745 or other references. The gap analysis reviews data provided by the manufacturer and provides: Overall impression on the technical documentation; Identifies specific gaps with criticality scaling; Estimates the effort with regards to achieving compliance. 3) Compilation of all regulatory documentation (CE mark, FDA): COVARTIM prepares the technical file using in-house templates and elements provided by the manufacturer, according to the MDR or FDA structure, as appropriate. Verification that any gaps identified in the gap analysis are closed, and the technical file is compliant before submission. 4) Support towards Notified bodies and Competent Authorities: COVARTIM is alongside the manufacturer during audits and inspections. COVARTIM efficiently supports to create CAPA plans and to solve the non-conformities.