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