ACL Digital’s Quality experts help clients transition to a data-driven digital Quality Management system that can adapt to changes in Regulations and Standards, mitigate the compliance burden, generate compliance-driven business insights, track Quality metrics, learn from patterns and trends and enable informed decisions that positively impact product quality. We work collaboratively with clients to formulate Quality strategies, build and manage Quality Systems compliant with ISO 13485:2016, 21 CFR Part 820 (for FDA) and MDSAP, as applicable.
Our product lifecycle approach addresses all aspects of Design Control, Document Management (compliant to 21 CFR Part 11), Requirements Management and Traceability, Manufacturing and Operations, Clinical Operations, Post-Market Sustenance, Risk Management, Quality Events such as Non-conformances & Deviations, Complaint Handling, Reporting, CAPA and Change Control processes.

Overview-Regulatory Affairs & Medical Writing

Our Services include

  • Evaluation of the adequacy of Quality Management Systems against the latest versions of Quality Standards and Regulations
  • Upgrade QMS to establish compliance to new Regulations 
  • Quality System Integration (when multiple Quality systems exist within the same company) 
  • Quality Metrics and Quality dashboards 
  • QMS SOP drafting, redlining or updating
  • Design Control Implementation
  • Design History Files (DHF) Management
  • Third party support for MDR, IVDR, MDSAP, ISO 13485 Audits, Supplier Quality Audits
  • Build or upgrade Quality processes associated with:
    • 21 CFR Part 11 and Document Management
    • Training
    • Requirements Management and Traceability
    • Risk Management
    • Labeling
    • Post-Market Surveillance (PMS), Compliance and Reporting
    • Quality Events (e.g., Non-Conformane, Adverse Events)
    • Complaint Management
    • CAPA
    • Change Control
  • Quality consultation in response to FDA warnings or new regulations