833.465.4837
Language 
ENGLISH 中文 ESPAÑOL DEUTSCH FRANÇAIS 日本語 한국어
Quality ISO Certifications & Product Documents News & Resources Contact
SEARCH

Learn More
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

160 Years of EtO

Industry talk continues about a future with less or no EtO sterilization. It is a sea change, even though the controversy first appeared decades ago. It is a far cry from the buzz of a 1928 discovery that the gaseous compound was an effective insecticide. EtO...

Learn More

Get Smart! Pairing Technology with Health Condition Monitoring

It is common to see headlines that cite the aging population for one reason or another. It is almost as common to see news of medical or pharmaceutical breakthroughs offering new hope of improving quality of life or even extending life span altogether.

As...

Learn More

When Innovation & Convenience Come Together: Prescription Delivery by Drone

I’ve never had such an appreciation for time, and how I spend it, as I do now as a working parent. There are so many things I try to squeeze into the few hours a day I get to spend with my son before his bedtime, and the last thing I want to do is spend that...

Learn More
BFS_12.17.19

Blow-fill-seal Technology Innovates Pharmaceutical Manufacturing

As Blow-Fill-Seal (BFS) manufacturing technology grows in popularity, pharmaceutical and biologics companies are forced to consider new challenges around cleanliness.

A blow-fill-seal (BFS) aseptic manufacturing process combines multiple critical steps of...

Learn More

Contact Us

CONTACT US

CHAT