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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

Sterilization 101

Sterilization 101: What You Should Know as a Packaging Engineer

The type (or modality) of sterilization used for a medical device can impact the materials chosen for the sterile barrier system. Therefore, as a packaging engineer, it’s important to understand what sterilization is, the different types of sterilization, and...

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Future of Flexible Packaging: 2022 FPA Student Challenge

It’s no secret that packaging for the medical industry comes with many non-negotiable requirements. The highly technical, one-of-a-kind innovations we pursue are our passion. Still, the industry is quick to agree that packaging innovation often starts in...

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Aldin Velic, CEO Magazine Interview

Purposeful Packaging

Asia is home to two thirds of the world’s population, yet the continent consumes only a small proportion of medical devices globally, with Europe and the United States consistently behind the majority of global demand.

This is where Oliver Healthcare Packaging

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A Film Is Not Just Film

When you say healthcare packaging, people often think immediately about sterilization methods. The focus of the conversation will then quickly turn to whether or not a breathable substrate is needed, what coating might work best, and the optimal sealing...

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