AUDITS AND INSPECTIONS
QFI offers a wide and comprehensive of audit and inspection services to the medical device sector. We operate a fully-documented process covering a wide range of regulations and jurisdictions.
Audit of goal-oriented, quality management systems and other systems are offered to every size of manufacturer, distributor, private label and other economic operators, also to supply chain – from raw material vendors, sub-tier supplies and full contract manufacturers. Types of audit conducted include product, production/ process and remote/ desk-top, completed according to client procedures or ours. Process-based audit can be conducted according to EN ISO 13485/9001 series (as appropriate).
We perform government-standard inspections, ranging from Establishment inspection conducted to FDA inspection guides and conformity assessment to EU Competent authority and Health Canada standard, inter alia. Assessment depth and standard is superior to Notified bodies; we are frequently engaged to reinforce company internal audit programmes and conduct mock or pre-inspections and audits.
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; we also conduct 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.
Consider using our audit services to complements or reinforce internal and supply chain/ vendor programmes, prepare by mock audit/ inspection and also resolve enforcement issues.
QFI conducts labour standards assurance system audit, QMS, scientific, technical and regulatory due diligence audits.