MEDICAL DEVICES

Microsoft Dynamics ERP For Quality and Compliance

AXSource Consulting supports global manufacturers, distributors, suppliers, CROs, laboratories, universities, packagers and labelers of medical devices in their successful navigation through applicable regulatory and quality processes by providing cost-effective and compliant solutions to facilitate product launches globally.

Our customers range from large, multi-national companies to small business entities, often virtually run. Our Regulatory & Quality Services include:

  • Regulatory Strategy
  • Gap Analysis
  • Liaison with Regulatory Authorities (pre-submission meetings, refusals or product holds)
  • Investigational Testing, Clinical Trials (e.g. ITA, IDE)
  • Market Access (e.g. Class II, III, IV device applications, STED, premarket notification-510(k), premarket approval-PMA, PDP, HDE, Technical File, Conformity Assessment, Declaration of Conformity, CE Marking)
  • Transitioning from CMDCAS ISO 13485 to MDSAP; certification consulting to MDSAP
  • Post-Market Regulatory services (e.g. License Renewals, Amendments, PMA Supplements)
  • Medical Device Establishment Licensing (MDEL), Facility Registrations
  • Custom Quality Management System (QMS), SOP Development, Implementation & Training
  • Advice on Recognized Medical Device Standards
  • Validation of Software for Medical Devices
  • Validation of Software in regulated Manufacturing Processes
  • Audit Support (Internal, Supplier Certification, Self-Inspections for compliance to GxPs (i.e. GLP, GMP, GCP, GDP & GVP))
  • Regulatory Agency Inspection preparation, co-hosting and closure
  • Expert opinions & support in litigations/ class action lawsuits