QMS & Certifications

Earning multiple medical device certifications and quality system approvals are the first step in earning your trust.
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RBC is in good standing with many agencies you recognize.

We are:

  • EN ISO 13485:2016 certification by NSAI
  • Applying agency marks for CE, TUV, CSA, South Korea

RBC has developed and implemented a Quality Management System to demonstrate our ability to consistently provide services and products that satisfy our customers, partners, regulatory bodies and other interested parties. We are committed to meeting all applicable requirements and continually improving the effectiveness of the Quality Management System. The Quality Management System reflects the corporation’s total commitment to achieving the goal of meeting the needs of our customers consistently, efficiently and safely.

The objective of RBC Medical Innovations is to provide accurate, on-time and on-budget services and products that satisfy our customers, partners, regulatory bodies and other interested parties. We are committed to meeting all applicable requirements and continually improving the effectiveness of the Quality Management System.

Quality Policy

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ISO 13485

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Terms

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Consider RBC as your design, development, and manufacturing partner.

RBC’s certified Quality Management System is based on 21 CFR 820 FDA Regulations, EN ISO 13485:2016 standards, and the US FDA cGMPs.

See our Portfolio, Design & Development and Manufacturing capabilities.

Medical Device Industrial Design

510(K), PMA, AND CE MARK SUBMISSIONS

Depending on your needs, RBC Medical Innovations can produce all or part of the design documentation required for a FDA 510(k) submission, pre-market approval, or a CE Mark technical file.
RBC Can Help