FDA’s 21 CFR Part 820 — Quality System Regulation (QSR) has not been updated since it was first released in 1996 . . . until now. Are you ready? Part of a panel at the conference discussing the ...

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

ProMed, a leading contract manufacturer specializing in medical-grade silicone and plastic components, provides comprehensive support for medical device, pharmaceutical, and combination drug-device ...

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 ...

We’ve all heard process validation horror stories. Validations can take years. Creeping elegance can take over. Product launches can be stopped in their tracks. When implemented correctly, however, ...

Medical device design and development has evolved over the years, notably influenced by market demands and regulatory requirements. Traditional design practices, beginning with a reliance on generic ...

Device makers are taking increased interest in product designs and assembly that support closed-loop recycling. A Branson plastic welding process can safely and nondestructively “unweld” plastics used ...

The integration of artificial intelligence (AI) into the design of medical devices heralds a new era in healthcare—one where innovation meets precision to significantly enhance patient outcomes. This ...

The Centers for Medicare & Medicaid Services (CMS) released a final procedural notice on Wednesday to expedite Medicare coverage of novel medical devices and get the devices to Medicare beneficiaries ...