MEDICAL DEVICE SINGLE AUDIT PROGRAM SERVICES
Manufacturers participating in Medical Device Single Audit Program (MDSAP) initiatives to fulfil inspection/audit requirements obligated by participating countries can rely on QFI specialists. Our MDSAP competence includes officially-recognised assessors and QMS specialists who devise and implement processes, systems and procedures to enable clients to comply with medical device single audit program participating countries’ regulations.
We specialise in MDSAP implementing projects, ranging from management and regulatory systems to producing required documents plus inspection documents to full MDSAP pre-inspection, gap analysis and support during official MDSAP audit by MDSAP registrars.
Additionally, we devise and deliver fundamental or practical MDSAP training.
Medical device manufacturers requiring MDSAP compliance solutions can rely on QFI. Whether implementing MDSAP processes and procedures for the first time in business operations or seeking to accommodate and integrate individual or all MDSAP participating country medical device regulation in an existing management system, preparing for official MDSAP audit or requiring support during such audit, desiring training or simply interested in identifying gaps between existing QMS and MDSAP-compliant management system, QFI can deliver high-calibre, competence and practical know-how.
To achieve these objectives, we produce MDSAP transitional arrangements for clients, including gap analysis, compassion checklist report and workshop, scrutinise MDSAP mandatory process element capability within your system, produce solutions and prepare you for official MDSAP audit.
Additionally, QFI can support clients receiving witnessed and for cause audit/ inspection, including compliance and enforcement inspection.