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.
ISO 13485 audit services
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.
ISO 13485 auditor services
- Quality System Gap Assessment
- Quality System Implementation
- 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
RCA’s QMS consultant team provides industry expertise and real-world experiences during each ISO 13485 audit. We can help you develop ISO 13485 compliance strategies that pass a notified body formal assessment and comply with quality regulations.
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:
We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.
As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.