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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

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Thanksgiving is a holiday of the heart, through the lens of gratitude. The year of COVID-19 has made that message shine brighter than any other year, if nothing else.

As we round the bend to sweep away 2020, we’ve been reminded of many things to be thankful...

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Behind the Scenes of Our Nurses Speak Up Video Series

Recently, I had the pleasure of virtually interviewing five operating room scrub nurses. I interviewed them as a part of our new video series, PackTalk: Nurses Speak Up. The goal of these interviews was to get real, honest feedback from healthcare...

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MedTech Conference Hot Topics

AdvaMed’s conference takes on medtech’s need to actively increase diversity and inclusion and fight racism, now.

If there is one thing we’ve learned in 2020, it is that our industry, along with others, must take a stand against racial injustice. AdvaMed’s...

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FDA

MD&DI Interviews FDA Commissioner

How the FDA continues to generate the science and data of a pandemic, keep the public health on active duty, and serve innovation, in the year that upended the world.

On April 1st, 2020, we published a blog post on the Herculean effort taking place between...

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