The Aspire team has significant experience working within a regulated environment. Our Quality Management System is certified according to ISO 13485:2016 by NQA (Global Certification Body accredited by ANAB). We are registered with the FDA and also compliant under QSR (21 CFR Part 820). We have experience with PMA and 510(k) applications and have been a chief testing facility on record for several submissions to the FDA.

FDA Registration number: 3003994148

Helpful Links:

FDA Guidance Document for Class II Tissue Adhesives

Code of Federal Regulations Title 21