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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.
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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

An Evolution of Vigilance

Since its inception, the pharmaceutical industry has been required to meet myriad, sometimes conflicting, priorities. And while patient safety has always been the cornerstone, early warnings still serve as sobering reminders for constant watch in an...

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A Shift to Data Driven Material Selection

Over the past couple of years, supply chain issues have been a common concern for everyone in the medical device and packaging industry. Companies have had to find ways to pivot or make do with the supply they have, and all of this has companies thinking....

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From the Operating Room to Medical Packaging

Jurgen Van Roosbroeck, Medical Segment Leader for the EMEA region at Oliver Healthcare Packaging, started his career in nursing, where he spent 10 years working in the emergency room, the intensive care unit, and the operating room. Years later, after working...

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The Impact of Radiation Sterilization Modalities on Flexible Sterile Barrier Pac...

The health and safety of patients is the number one priority when it comes to sterile barrier packaging and sterilization. As a packaging engineer, it is important to understand the relationship between radiation sterilization modalities and flexible sterile...

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