Tag: Manufacturing Tips

Precision Plastic Parts

3 Types of FDA Inspections and What That Means for Medical Manufacturing Companies

Medical manufacturing companies know the consequences of failing to adhere to FDA (The U.S. Food and Drug Administration) regulations can have severe repercussions. One glance at the U.S. Department of Justice and the U.S. Department of Health and Human Services joint annual report on health care fraud and abuse control shows approximately $3.3 billion in… Read more »

Clean Room Manufacturing

How to Create an Easy Transition From the Validation Process to Manufacturing

One of the most important phases of a medical product development life cycle is the relationship between your company‚Äôs validation expert and the original equipment manufacturer (OEM) of your medical product. It is the test run for approval and commercialization. The importance of the transition from validation process to manufacturing will determine FDA approval, the… Read more »

Class 1 Medical Devices

How to Choose a Medical Contract Manufacturer

Deciding on the ideal medical contract manufacturer (CM) can be a difficult process, as there are many aspects to consider. Medical device CMs play a critical role in the medical device manufacturing process for original equipment manufacturers (OEMs) whether it’s a need for casting and molding, R&D design, or custom packaging. As a medical instrument… Read more »