Today's injection mold manufacturers are much more than 'just moldmakers.' As OEMs - particularly those in the medical and automotive industries - become more and more dependent upon their supply ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

Despite their frequent interchangeable use, understanding the distinction between validation and qualification is critical in pharmaceutical environments. Validation is a broader concept encompassing ...

Laser micromachining is a versatile process that can be used for an array of medtech applications. Yet when using it, it is crucial to select the appropriate method of process qualification or ...

In highly regulated industries, quality and validation procedures can be make or break, and getting them right requires working with system integrators who have industry-specific experience. My first ...

In the medical device world, laser welding encompasses a wide range of applications and part sizes. However, when laser-welding process cannot be fully verified, FDA requires that manufacturers ...

Global regulatory expectations for approaches to process control and validation are changing. It is essential that those involved with and responsible for process validation attend a special PDA ...

Introduction: As the automotive industry embraces advanced technologies, ensuring the safety and reliability of critical systems has become paramount. ISO 26262, an international standard for ...