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RND provides software services for life sciences, R&D, and Medical Devices that comply with the FDA’s 510(k) and PMA requirements. RND’s vendor approved quality system is compliant with both the FDA’s 21 CFR Part 820, and the ISO/DIS 13485 standards for quality systems. RND has also delivered systems compliant with the FDA’s 21 CFR Part 11 for Electronic Records Management.
RND is an approved vendor to supply software services to a number of global industry leading medical product companies. |
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- FDA 510(k), PMA, CDHR, CBER
- 21 CFR Part 820 – Quality System Regulation
- 21 CFR Part 11 – Electronic Records
- ISO 9001, 13485 – Quality System Requirements
- SEI CMMI Capability Maturity Model
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