QA Consulting, Inc.

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 strategy
– Post-market compliance
– Microbiology (biocompatibility, bioburden, endotoxin, sterility, and more)
– Helping startups bring their first product to market

Lean into quality with medical device systems everyone can trust.

Company’s Keywords:

medical device consulting, regulatory strategy, microbiology, iso 13485, quality management systems, cleanroom qualification, sterilization validation, bioburden testing, biocompatibility, endotoxin, audits, fda 483, 510 premarket submissions, predicate selection, risk management, risk planning, design controls, document control, design transfer, process validations