I highly recommend this firm as an excellent source for regulatory strategy and approval, biocompatibility assessment and strategy, product / project risk management, etc. for all stages of product development through product realization. The firm is ISO 13485 registered. Personally, I've utilized QA Consulting for the past 6 years for sterilization validations, biocompatibility assessments, and internal audits and QMS strategy. I have been most pleased with the knowledge, output and responsiveness of the staff.

-Senior Quality Assurance Director