Quality system consulting for medical device manufacturers, distributors and supply chain. Specializing in compliance witH 21 CFR Part 820 for medical devices.
Providing expert consulting to FDA-regulated industries and their global counterparts with expertise in quality management systems development and implementation, compliance readiness, and GMP assessment, with a special focus on medical devices.
Areas of Expertise include: FDA-Regulated Industries Worldwide. Developing, implementing, and maintaining quality-system compliance programs (CAPA). Establishing quality systems infrastructure to support regulated industries. Quality-system assessments for compliance to FDA regulatory requirements and ISO and EN standards. Compliance audits and remedial action. Training and education for all elements of the U.S. FDA medical device quality system requirements (GMP) and FDA inspection readiness
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