Our Experience includes
Development and implementation of quality systems
Computer system validation
Total IT compliance solutions
Laboratory equipment qualification (specializing in Clinical Pathology instrumentation)
Commissioning and qualification of new or existing facilities
Vendor/supplier audits in FDA, CLIA and HIPAA-regulated environments
Pre-subs and 510k for Medical Devices
SDLC for Regulated Markets
HIPAA audits and policies (www.hipaability.com)
The BiggsB teams provide integrated services; from project conception through planning and into project approval and implementation. We not only assist in completion of the entire project life cycle, but also identify and recommend alternative solutions which save our clients money in the long run.
Each member of the BiggsB team has a minimum of 10 years of experience in compliance, regulatory, and project management experience. And we recognize that true leadership comes not only from knowledge of the industry, but from the ability to manage people and develop a customized plan of action for every project.