KSL Biomedical services

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.

KSL Biomedical, Inc. (“KSL”) was founded to deliver innovative diagnostics and therapeutics. KSL has professionals with many decades of experience in US and international regulatory compliance, product design and development, clinical trials, and protection of intellectual property to work with health care industry partners to address their need for special resources to achieve and maintain compliance. Team members have worked with all levels of compliance: state, national and international inspectors, regulatory authorities and quality registrars in the laboratory service, medical device, in vitro diagnostic (IVD) device, pharmaceutical, food and supplement fields.