Laboratories, whether clinical or non-clinical, have to follow certain Good Laboratory Practices (GLP). Nonclinical...
Gabe Kadoo
Reporting Timelines for Adverse Events
When an event occurs related to a medical device there is the need to determine if it qualifies as an adverse event...
Types of Regulatory Audits
There are many different types of Regulatory audits that can be conducted. These are audits that upon successful...
When to Pursue Quality
Quality is something that should be integrated into an organization. To pursue quality means to drive forward...
EU Technical Files
A concept similar to the FDA’s Design History Files, the EU Technical File is a collection of documents related to the...
Pharmaceutical QMS
A quality management system, QMS, is a crucial requirement for any organization in the life sciences industry....
Risk Mitigation
Whenever risk is identified whether it is part of a process or the design of a product, mitigation of the risk needs...
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 itself...
The Importance of a CoA
A Certificate of Analysis, CoA, is a document, usually issued by an organization’s quality department, that asserts...
Good Documentation Practices
Whether it is an SOP or a test report, there are certain practices that everyone should follow in order to create a...
Compliance VS Quality
Compliance and quality, while similar, can also be strikingly different. Many companies treat quality as nothing more...
Conducting a Risk Assessment
A Risk Assessment is yet another powerful tool in a professional’s arsenal that, if used effectively, can greatly help...
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