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.

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

Regulatory & Validation

With years of experience in the global manufacturing industry, we understand the global regulations you face. Let Oliver help you navigate them.

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.

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.

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

COVID-19 Testing Supply and Capacity May Be Key to Reopening the Economy

Since the first confirmed COVID-19 case reported in the United States in late January, the nation has seen more than 1.6 million confirmed cases and approximately 96 thousand deaths. This number has risen higher than anticipated while states have been staying...

Learn More

Global Medical Device Regulations & Harmonization Efforts of Sterile Medical Pac...

We are going through a global health crisis which is unprecedented in our lifetime. This is a global pandemic which requires an international response. As such, it becomes even more important to understand global harmonization of best practices in the...

Learn More

The FDA Authorizes First COVID-19 Saliva-Based Test for Home

With COVID-19 test kits in high demand, the FDA has been authorizing new at-home sample collections to help make tests more accessible.

Until this point, all at-home tests have required collection from a patient’s nose using a nasal swab and saline. But,...

Learn More

What Mass Testing Means for the Packaging World

As the world fights the COVID-19 pandemic, the tone in America has shifted since the initial battle cry to “flatten the curve.” The lockdown of schools and non-essential business has passed the 10-week mark and caused a counter-reaction to re-open businesses,...

Learn More

Quality

Exceeding Standards

Everything we do as a company is based on one thing: ensuring patient safety.

Continuous Improvement

Regulatory & Validation

Recently Published Articles

COVID-19 Testing Supply and Capacity May Be Key to Reopening the Economy

Since the first confirmed COVID-19 case reported in the United States in late January, the nation has seen more than 1.6 million confirmed cases and approximately 96 thousand deaths. This number has risen higher than anticipated while states have been staying...

Global Medical Device Regulations & Harmonization Efforts of Sterile Medical Pac...

We are going through a global health crisis which is unprecedented in our lifetime. This is a global pandemic which requires an international response. As such, it becomes even more important to understand global harmonization of best practices in the...

The FDA Authorizes First COVID-19 Saliva-Based Test for Home

With COVID-19 test kits in high demand, the FDA has been authorizing new at-home sample collections to help make tests more accessible.

What Mass Testing Means for the Packaging World

As the world fights the COVID-19 pandemic, the tone in America has shifted since the initial battle cry to “flatten the curve.” The lockdown of schools and non-essential business has passed the 10-week mark and caused a counter-reaction to re-open businesses,...

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