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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

FDA Pilots Programs to Enhance Traceability

What is happening with FDA Title II Drug Supply Chain Security Act (DSCSA)?

In October 2014, the FDA issued draft guidance in response to Title II (a/k/a the DSCSA) of the Drug Quality and Security Act (DQSA) of 2013. The requirements and compliance deadlines...

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Heat Seal Packaging

Heat Sealing Advances Heat Up

"The benefit of machine-intelligence technology is risk mitigation." - Kent Hevenor

It is no secret that heat sealing has been a perennial mainstay in the process of medical device and pharmaceutical product development. Rapid technology advancements are...

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At Home Drug Delivery

Do It Yourself Healthcare

Chances are that you know someone who lives with a chronic condition that requires ongoing, regular treatment. Often, that treatment includes injections. More than ever, patients and families are finding themselves being transitioned from office visits to...

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technology in healthcare

Where COVID-19 and Innovation Collide

It’s no shock that COVID-19 has changed (and will forever change) our lives, including the way we do business. Everyone, across every industry, has been challenged to get creative and innovate. Restaurants have created digital menus and mobile applications...

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