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.

ISO 13485 Certified


Cleanroom Manufacturing


ISO 14971 Risk Management Compliant

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

Oliver's commitment to patient safety and product quality is driven by top management and shared by all Oliver employees. We're proud that our quality program meets the stringent standards of medical device, pharmaceutical, and diagnostics manufacturers worldwide. Review our standard quality survey below.

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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."

Regulatory & Validation

With years of experience in the global manufacturing industry, we understand the global regulations you face. Let Oliver help you navigate them.
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.
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.
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).

Industry Education

The 4 Pillars of Packaging Validation

Break down the 4 Pillars of Packaging Validation: Use, Make, Ship and Store, and understanding ISO 11607 requirements with Packaging Compliance Labs.

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History of Expiration Dates

In 1979, a US study on food expiration dates exposed challenges. The study showed that while consumers felt happier, there was “little evidence to support or negate the contention that there is a direct relationship between open shelf-life dating and the actual freshness of food.”...

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Packaging 101: ISO 11607

When you first enter the medical packaging industry, you’ll frequently hear about ISO 11607. Here, we share the top six things you need to know about ISO 11607.

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Unwritten Rules of ISO 11607

Many industry veterans know that parts of ISO 11607 are up for interpretation. This is our quick, expert guide to the areas of ISO 11607 that are more open to interpretation than others.

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Root Cause Analysis Checklist

Use this checklist when looking for the root cause of a breach in the sterile barrier of a tray or pouch.

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