The new EU MDR 2017/745 is complex, to say the least. Depending on a company’s relationship to the medical device the...
Guidance
The FDA, CBD, and OTC Drugs
When making a new product, whether that product is a drug, a medical device, or a combination product,...
Human Error in Corrective and Preventative Actions
When an error occurs, corrective and preventative actions are developed to help strengthen the quality...
QMS For CBD Companies
Around the world, there are different regulations regarding the cultivations, manufacture, and sale of...
Labeling Compliance of CBD Products
One of the main reasons the Federal Food and Drug Administration issued warning letters to CBD companies or...
A Brief Guide to Quality Objectives
As 2021 has come to a close and companies are holding and finalizing their last management reviews, quality...
Symbols for Medical Device Labels
Labeling for medical devices is under strict regulations. The requirements are dependent on the class of...
Design and Development Planning
Developing a Design and Development Plan is a part of the design controls process required by the FDA for...
Common Mistakes Made when Handling Complaints
Manufacturers may find themselves without the resources and processes needed to effectively and efficiently manage...
Non-Conforming Material Reports
A Non-Conforming Material Report or NCMR is the standard way to report a material that does not meet the...
Proctor & Gamble Cosmetic Recall
On Friday, Proctor & Gamble announced a voluntary recall of several of their aerosol dry shampoo and...
What to Do with a Bad QMS
For most of the major sections of the life sciences industry, a proper Quality Management System (QMS) is...
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