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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

Europe’s SBA: A 30-year Career and Counting

The April 2022 biannual gathering of the European Sterile Barrier Association offered its industry professionals business-as-usual – familiar discussions of healthcare trends, sterile barrier packaging issues, and group work on a member project, yet there was...

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How to Approach Curving or Coiling Long Catheters

Long catheter systems can be a complicated problem when it comes to package design. As the name suggests, they are long and awkward to handle for manufacturing personnel, storage facilities, and end users. Considering alternative packaging configurations,...

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"Time is Brain" - A Lesson from Cath Lab Veterans

In our articles, we often focus on doctors and nurses, but there are so many people in other settings that support life changing procedures. This article is for them, with a specific focus on Registered Radiologic Technologists (RT), and the important role...

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Asia-Pacific Location Ramps Up to Meet New Challenges

The Asia-Pacific healthcare packaging industry continues to experience incredible growth with innovation, sustainability and speed-to-market as top priorities. With Covid-19 restrictions finally starting to ease, how will this shape priorities for 2022 and...

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