QA Consulting, Inc. Information

QA Consulting, Inc. is your trusted thought partner for innovative medical device consulting and outsourced quality assurance services tailored to meet your objectives throughout the product lifecycle. We offer custom solutions in the areas of: - Quality Systems - Regulatory Affairs - Microbiology Analysis From startups to multinational corporations, discerning medical device manufacturers of all sizes rely on our real-world knowledge, expert documentation, and mastery of industry protocols and procedures to navigate today’s constantly evolving regulatory environment. We are quality connoisseurs that help you jump through compliance hurdles with ease. Our areas of expertise include: - Quality system development - Audits (internal, supplier, notified body) - U.S. FDA and EU regulatory strategies - Regulatory submissions - EU MDR and IVDR - Post-market compliance - Microbiology (bioburden, cleanrooms, sterilization qualifications and more) - Helping medical device manufacturers achieve compliance Lean into quality with medical device systems everyone can trust.