Quality Compliance

KSL CRO Services team are well versed in quality compliance including requirements from ISO 13485:2016, 21 CFR Part 820 Quality System Regulation (QSR) and In Vitro Diagnostic Regulation (IVDR). KSL's team provides quality compliance services for start-ups and well-established companies looking to build out Quality Management System (QMS), maintain and improve current QMS, meet new regulatory requirements such as those of IVDR, or expand with new needs on QMS. KSL team also provide quality audit services including ISO 13485-, FDA QSIT-, and Medical Device Single Audit Program (MDSAP)-style quality audit, and supplier qualification quality audits. KSL has provided consulting services to companies with various sizes with sustainable and effective quality compliance solutions.

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QMS establishment: 

  • QMS design and implementation: from design, development, to implementation of the entire QMS that are compliant to ISO 13485:2016, QSR and IVDR

  • QMS improvement: KSL provides GAP analysis on your existing QMS and works with you to provide strategy and training for your QMS improvement. 

 

Quality compliance audit: 

  • ISO13485:2016-based quality audit

  • MDSAP-style quality audit

  • FDA QSIT-style quality audit

  • Supplier qualification audit

  • Pre-approval audits