AUDITUS

Quality First International provides:

  • Assessment of product design, calculations, working drawings, control systems, equipment specifications and Quality System against International and Harmonised European Standards
  • Verification of conformity of relevant documents against the appropriate international and Harmonised European standards, Consensus and other recognised Standards
  • Examination of Technical Documentation according to relevant national and international Regulations
  • Verification that inspection, supervision, test and document control satisfy production process Requirements

QFI assesses any existing Quality Management System (QMS) documentation for compliance with regulations and standards and prepares a comprehensive remedial plan to bring the system into compliance. This can include all contributing subcontractors, including any declared responsible on a device label are subject to audit against the requirements of the conformity assessment procedure of the principal manufacturer and is conducted in several phases.

QFI helps to conduct internal audits when:

  • The scope of the assessment surpasses the abilities of the Notified Body
  • A corporation wishes to outsource internal audit resources
  • An internal audit programme needs external support
  • Compliance verification is desired
  • Conformity Assessment Procedures (CAP) are required for integration into a corporation
  • Technology audit is desired
  • Due diligence is required to the highest standard, including start-up and blue-chip

QFI auditors will:

  • Conduct exhaustive audits and inspections according to client company procedures or our internal QMS audit procedures
  • Include technical assessment of product, process and service functions
  • Ensure the audit is unfettered unlike Notified Body and other Conformity Assessment Body audits
  • FDA and Competent Authority inspections, etc
  • MDSAP inspection
  • Evaluate regulatory compliance
  • Identify any gaps that exist between the relevant standards and the processes implemented
  • Create a remedial action plan arising from audit findings and examination of supporting documentation
  • Formulate recommendations and instructions to implement changes
  • Improve the overall efficiency of your Quality Management System

Quality First International performs regulatory compliance audits and inspections to levels expected and practised by Governmental organisations (notably the Competent authority UK (MHRA),  FDA and European Competent Authorities) and surpass Notified Body scrutiny. We offer outstanding external resources in support of medical device manufacturers, vendors, and distributors (internal) audits. Our team of technically competent and experienced product specialist auditors bring to the auditing process exceptional scientific, technical medical device regulatory, organisational and Quality System knowledge.

Auditus is particularly useful:

When an audit is undertaken to verify that the manufacturer has:

  • Conclusively demonstrated full application of regulations and standards appropriate to the intended geographical marketplace
  • Appropriate infrastructure and resources
  • Appropriate product life-time design control
  • Adequate means of identifying and reporting alleged adverse events
  • Adequate Technical Documentation to support the CE mark, FDA approvals, Health Canada approvals, etc

or

When Expert Witness evidence is necessary as part of Due Diligence or preparations in defence of possible regulatory enforcement.

QFI performs medical device system compliance audits against:

  • US regulations
  • UK medical device regulations
  • European medical devices Directives
  • Canadian regulations
  • Australian regulations
  • EN ISO 9001 et seq
  • EN ISO 13485
  • Due diligence for mergers and acquisitions

Assessment includes:

  • Meticulous scrutiny in defence of regulatory enforcement
  • Quality System provisions
  • Production facilities
  • Technical review of production
  • Subcontractor’s premises
  • Final product inspection
  • Testing techniques
  • Product design

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