Resource Center

Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.

Reporting Adverse Events

Reporting Adverse Events

Post-market surveillance is necessary for ensuring compliance as regulatory bodies have the authority to impose ...
Label Changes and the 510k

Label Changes and the 510k

Submitting a 510k for a medical device can be a long and confusing process. When a 510k is submitted the device ...
CE Marks under IVDR

CE Marks under IVDR

The COVID-19 pandemic has changed the world by disrupting global supply chains and impacting human health. This ...
The Importance of a CoA

The Importance of a CoA

A Certificate of Analysis, CoA, is a document, usually issued by an organization’s quality department, that ...
Continuous Improvement: PDCA

Continuous Improvement: PDCA

Continuous improvement is the ongoing improvement that can occur in all settings and many aspects of a company. It ...
Good Documentation Practices

Good Documentation Practices

Whether it is an SOP or a test report, there are certain practices that everyone should follow in order to create ...
The Upcoming IVDR Transition

The Upcoming IVDR Transition

Many companies in the industry have been preparing for the In Vitro Diagnostic Regulation (IVDR) rollout since it ...
Compliance VS Quality

Compliance VS Quality

Compliance and quality, while similar, can also be strikingly different. Many companies treat quality as nothing ...
Conducting a Risk Assessment

Conducting a Risk Assessment

A Risk Assessment is yet another powerful tool in a professional’s arsenal that, if used effectively, can greatly ...

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