bg-quality-sized

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

Georgiana_RD2-1-1
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

Improved Testing for COVID-19

Pulling Together To Fight COVID-19

Thermo Fisher Scientific, Mayo Clinic, and Roche Get FDA Approval to Help in Fight Against COVID-19.

As we all pull together in the fight against COVID-19, it is encouraging to read details about the FDA’s fast tracking of COVID-19 diagnostic tests under...

Learn More

COVID-19 Update

To Our Valued Customers:

First, let me begin by saying this: I hope you and your families, friends, and colleagues are safe and healthy during this challenging time. I recognize that many in the healthcare community are fighting COVID-19 from the front lines,...

Learn More
1 lb Seal Strength

Seal Strength Testing: Is 1 lb. Still the Go-To Metric? ASTM WK57656 Update

A few years ago, I started a journey on behalf of packaging professionals everywhere—to validate or debunk the 1 lb. standard for seal strength testing. For as long as I can remember, it has been a popular topic of conversation and debate in every gathering...

Learn More

Looking Ahead: The Future is Flexible

Recently, China decided to ban imports of foreign recyclable material. At the same time, the EU is waging its own war against plastic waste.  As a result of these major initiatives, manufacturers from all industries have started to feel the pressure to create...

Learn More