Among our offerings, we provide experienced consultants to assist clients in the medical, pharmaceutical, biotechnology, and other life science industries with validation, quality, compliance, auditing, and system issues, and to achieve compliance with FDA, CE marking, and ICH guidelines, and regulations.Black Diamond’s Quality Engineering services group is dedicated to supplying the quality, safety, validation, regulatory and compliance experts that ensure clients’ medical devices, medicines, delivery systems and therapeutic products are the safest and most reliable in the world. Within this technology segment, our industry knowledgeable recruiters have rigorously and persistently sought out the most highly-specialized and proficient talent nationwide making our Quality group uniquely qualified to respond quickly and confidently to client’s critical contract resource needs.Specialties:Regulatory Affairs 510k submissions, IDE, AER’s, PMA’s, remediation/resolution, Validation: validation protocols (IQ, OQ, PQ); validation master plans;(LIMS);(SOP); process validation; facility qualification;(CSV); equipment qualification; utility systems validation; cleaning validation; TMV; packaging validation; 21 CFR Part 11.Quality: Gap/ Risk assessment; MDR’s, Documentation, CE marking, international standards, complaint handling; auditing; QSIP, vendors, deviation ; CAPA, design control
Listed skills include Fda, Validation, Regulatory Affairs, Medical Devices, and 19 others.
