Meeting standards is easy. Going above and beyond is what sets Oliver apart.
The best systems are those derived from a continuous improvement program. Whether it’s meeting the strictest ISO standards and FDA regulations, implementing vision inspection technology, or investing in our facilities, we relentlessly seek new ways to improve. We are further developing all aspects of our operation model.
All sites are ISO 13485 certified
Annual cGMP Training for all employees
Statistical Sampling (ASQ/ANSI Z-1.4, Z-1.9 and C = 0) Z-1.4, Z-1.9 and C = 0)
Robust Validations IQ, OQ, PQ for ISO 11607 Part 1 and 2
Independently ISO 14644-1 certified cleanrooms
21 CFR Part 11 document management system
The FDA perspective on human factors and usability in health care was first published on July 18, 2000, with the issuance of US FDA draft document, “Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management.” That non-binding...
In the past 18 years of my career, I have been blessed...