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Quality

From maintaining the highest standards for our cleanrooms, to investing in our employees, our commitment to quality is at the very core of everything we do. With this dedicated approach, we aim to consistently meet and surpass your expectations at each step of the process.

Exceeding Standards

Meeting standards is easy. Going above and beyond is what sets Oliver apart.

Everything we do as a company is based on one thing: ensuring patient safety.

From investing in research and development, to challenging our test methods and procedures, to developing new packaging solutions, we are wholly committed to not only meeting the highest standards, but exceeding them.

Continuous Improvement

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.

ISO Certifications

 

  • 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

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Our Quality Policy
"Our highest priority is to exceed customer expectations through exemplary service and the supply of high quality products to ensure patient safety. We are committed to maintaining the effectiveness of the quality management system through the review of quality objectives and compliance with regulatory requirements."
Georgianna Gallegos, Vice President of Global Quality

Regulatory & Validation

With years of experience in the global manufacturing industry, we understand the global regulations you face. Let Oliver help you navigate them.
fda22
Time and again, US-based manufacturers and distributors count on the expertise of our on-site process validation services to guide you through the regulatory requirements established by the FDA for Class I, II and III medical devices.
eu-mdr
In 2020, new European Medical Device Regulation (EU MDR) will seek to increase medical device safety and effectiveness in the European market. We’re armed with the tools to help our customers meet the packaging challenges presented by these new protocols.
CFDA
With an increase of on-site audits, our knowledgeable and experienced validation team can help ensure that our customers’ devices comply with the eight principles for clinical trial inspections established by the China Food and Drug Administration (CFDA).

Recently Published Articles

Human Factor & Usability in Healthcare

Human Factors & Usability: An Interview with Expert Shannon Hoste

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...

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The Quick Pace of Evolution in Healthcare Packaging for Developing Nations

Evolution in the healthcare packaging industry is much quicker in developing nations than it is in more developed countries. Continuous improvement is all about minimizing risk while getting products to market quickly is still a top priority. So, what are the...

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5 Lessons I Learned from My Experience in Healthcare Packaging

“Personal development is your springboard to personal excellence. Ongoing, continuous, non-stop personal development literally assures you that there is no limit to what you can accomplish.” – Brian Tracy

In the past 18 years of my career, I have been blessed...

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The Gorilla in the Room

When I first sat down to write this article, a myriad of topics came to mind. There is a LOT going on right now–technical, business, professional development, and more… I think what I’m going to go after today is a bit more abstract than normal, but...

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