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.
Industry
Medical Equipment Manufacturing
HQ Location
7500 Rialto Blvd
Bldg. 1, Ste. 250
Austin, Texas 78735, US
Keywords
medical device consultingregulatory strategymicrobiologyISO 13485quality management systemscleanroom qualificatiosterilization validatiobioburden testingbiocompatibilityendotoxi