![]() ![]() We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.Īs 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. 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. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges: ISO 13485 Certification, ISO 13485 Consultants, ISO 13485 Documentation, ISO 13485 Consultancy, ISO 13485 Training, ISO 13485 Audit, ISO 13485 Internal. We can help you develop ISO 13485 compliance strategies that pass a notified body formal assessment and comply with quality regulations. RCA’s QMS consultant team provides industry expertise and real-world experiences during each ISO 13485 audit. Medical Device Single Audit Program ( MDSAP) Readiness Audit.Standard Operating Procedure (SOP) Development.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 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. RCA’s consultants are Quality experts with experience spanning start-ups to international Fortune 100 corporations. Preparation, Training, and Inspection Readiness.Mergers and Acquisitions / Due Diligence ISO 13485 Certification Transition Consultants for Your Business transparency of product design and development risk management and applying ISO 14971.Manufacturing Optimization and Aging Facilities.Part 11 and Computerized System Validation.Technical File and Design History File (DHF). ![]()
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