Water Quality and Contaminants in Laboratory Use
3 minute read

Water Quality and Contaminants in Laboratory Use

Water is one of the major utilities used by the pharmaceutical industry. It is used during the production of the finished product or as a cleaning agent for rinsing...

Why Do Medical Devices Need to Go Through Validation?
3 minute read

Why Do Medical Devices Need to Go Through Validation?

The Contract Development and Manufacturing Market is expected to grow to $100 Billion by 2025, an 11.4% CAGR. This growth is partially fueled by the increasing burden of...

3 Design Considerations for Manufacturing Medical Grade Face Masks
3 minute read

3 Design Considerations for Manufacturing Medical Grade Face Masks

Surgical masks and respirators are an essential part of the personal protective equipment used in the healthcare sector to combat respiratory infections. They're worn...

Demystifying Failure Mode and Effects Analyses (FMEAs) in Medical Device Manufacturing
4 minute read

Demystifying Failure Mode and Effects Analyses (FMEAs) in Medical Device Manufacturing

Failure Mode and Effects Analysis (FMEA) is a design review tool used to identify and correct all possible failures in a product, service, design or manufacturing...

Biocompatibility Testing for Surface Medical Devices
4 minute read

Biocompatibility Testing for Surface Medical Devices

All medical device companies must subject their products to a volley of FDA-approved tests to establish the safety of their devices. A particular series of these tests...

What Does the Implementation of EU-MDR Mean?
3 minute read

What Does the Implementation of EU-MDR Mean?

The passing of the EU Medical Device Regulations (EU-MDR) is forcing medical device manufacturers to update their clinical testing practices and reporting mechanisms....

Characteristics of Successful Medical Device Product Launches
4 minute read

Characteristics of Successful Medical Device Product Launches

The creation of a new medical device involves many steps from initial concept to finished product. Every year billions of dollars are invested in research and...

The Top Reasons Why Medical Devices Fail
4 minute read

The Top Reasons Why Medical Devices Fail

Medical device failures are typically the result of deficiencies in safety check procedures or a lack of attention to potential risks in the design process. Often...

The Evolution of US Medical Device Regulation
3 minute read

The Evolution of US Medical Device Regulation

Medical devices are regulated according to the same legislation as food and pharmaceuticals, under the general organization of the Food and Drug Administration (FDA)....

1 2