AUDITS AND INSPECTIONS

QFI offers a wide and comprehensive range of audit and inspection services to the medical device sector operating a fully-documented process covering a wide range of regulations and jurisdictions. QFI assesses any existing Quality Management System (QMS) documentation for compliance with regulations and standards and prepares a detailed remedial plan to bring the system into compliance.

Audit of goal-oriented QMS and other systems is offered to every size of manufacturer, distributor, private label and other economic operators also to supply chain – from raw material vendors, sub-tier suppliers and full contract manufacturers. Types of audit conducted include product and production/process, completed according to client or QFI procedures.

QFI performs government-standard inspections, ranging from Establishment inspection conducted to FDA inspection guides and conformity assessment to EU Competent Authority and Health Canada standard.

Additionally, QFI offers services to assess critical sub-contractors and crucial suppliers according to Commission Regulation 2013/473 (EU) and associated Market surveillance regulations.

QFI’s high-calibre technical specialists conduct product audit and assessment exceeding Notified body standard, specialising in high-risk and forefront product; QFI also conducts EU design-examination assessments, including on combination products, devices containing or derived from animal/ human tissue and other class III products; product technology and special process audits.

Additionally, QFI conducts labour standards assurance system (LSAS) audit, QMS, scientific, technical and regulatory audits for due diligence purposes plus MDSAP inspections.

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