RCA’s consultants are Quality experts with experience spanning start-ups to international Fortune 100
corporations. We know first-hand how to achieve, maintain, and improve quality in the medical device industry, and we excel in transferring this knowledge to your organization.
Whether you are just beginning your journey to certification or you are faced with aggressive timelines to meet the ISO 13485 or MDR transition deadlines, RCA’s quality assurance experts can help.
We provide services such as:
- Quality System Gap Assessment
- ISO 13485 Quality System Implementation
- ISO 13485 Quality System Transition
- Standard Operating Procedure (SOP) Development
- Document Control Implementation
- Design Controls
- Design History File Creation
- Risk Management (ISO 14971)
- Readiness Audits
- Medical Device Single Audit Program (MDSAP) Readiness Audit