In today’s fast-paced and tightly regulated medical device industry, a Quality Management System (QMS) is far more than a mere compliance exercise, especially for medical device manufacturers. In this article, we will tell you the ins and outs of QMS...
Standard Operating Procedures (SOPs) are the backbone of quality management systems in the life sciences industry. Whether you're working in pharmaceuticals, medical devices, or biotechnology, SOPs ensure consistency, compliance, and safety in proces...
In 2024, the FDA released its long-awaited final rule that reshapes how U.S. medical device manufacturers manage quality.
GMP stands for “good manufacturing practices.” Life sciences companies need to be GMP-certified in order to produce and sell their products. But what do GMP guidelines entail? And how is GMP different from cGMP, or “current good manufacturing practic...
Staying ahead of industry shifts has never been more critical for anyone working in biotech, pharma, or MedTech. The pace of innovation is accelerating, regulatory expectations are tightening, and AI is reshaping everything from discovery to commerci...