Compliance & Quality Management

ARC's Research Quality division delivers the full spectrum of Quality Management, Compliance and Auditing services.

ARC offer a flexible, quality-driven, innovative approach to regulatory compliance. Working with you to help smooth the pathway to project completion by embedding quality and compliance in every stage of your specific project milestones.

ARC’s senior consultants have in excess of 20 years’ experience in a variety of industry sectors, and can offer bespoke quality assistance based on your individual needs. We offer a GCP compliant approach and can support quality systems including ISO 13485, ISO 14155, ISO 20916 and more; providing global expertise in quality management tailored to your requirements.

Get in touch to arrange a meeting with the team to discuss how ARC can support your Quality Management and Compliance requirements.

Services include:

  • Hosting and assisting Regulatory Authority Inspections
  • Sponsor or study site monitoring assessments
  • GCP assessment
  • Remediation work
  • Audits and related risk-based audit schedules
    • Supplier/Vendor quality audits
    • Documentation
    • TMFs
    • Clinical/investigational sites
    • For-Cause audits
    • Inspection readiness
  • Assessment / development of GCP quality system
  • Onsite / remote quality support
  • Training
  • Bespoke Quality consulting services

Quality Management:

  • Quality System audits and assessments
  • Document control
  • Design control support
  • SOP development
  • Supplier quality and purchasing controls
  • Complaints
  • CAPA
  • MDR and IVDR processes and systems
  • 21CFR 820 regulations and compliance

Compliance:

  • Good Clinical Practice (GCP)
  • ISO 20916 (IVDs)
  • ISO 13485 (Medical Devices)
  • ISO 14155 (GCP for Medical Devices)
  • CE Marking and product safety EU Directive
  • Competent/Reg Authority registration
  • Medical Device Directive (MDD) (93/42/EEC) and transition support to MDR (2017/745)
  • In Vitro Diagnostic Directive (8/79/EC) and transition support to IVDR (2017/746)
  • Quality Management System (QMS) in compliance with ISO 13485US 21 CFR 820 Quality System (QS) Regulations
  • ISO14971 Medical Device Risk Management