Scilife Blog

Medical device teams often spend months perfecting a breakthrough design. But the moment ISO 13485 certification and compliance enter the picture, momentum often grinds to a halt. The quality team has been brought in too late. Documents are scattered...

ISO 13485 audits can intimidate anyone. It sounds rigid and technical, and like it is designed to catch you out. This is why in this article we will walk you through how to prepare for an ISO 13485 audit, without the stress.

When working with medical device companies, one thing becomes very clear: the difference between a team that’s audit-ready and one that’s constantly chasing documentation often comes down to a single factor—training. If quality and compliance trainin...

The prime directive of medical device manufacturers is the continued safety of patients through safe and effective medical devices. A critical aspect of medical device safety is ensuring regulatory compliance of any medical device destined for the co...

As of February 2, 2026, the FDA’s Quality Management System Regulation (QMSR) is officially in force. The FDA’s new Quality Management System Regulation (QMSR) represents the most significant overhaul of U.S. medical device quality requirements in mo...

Medical devices are a vast category of equipment, treatments, and functional aids, ranging from caries detection software to contact lenses, orthopedic implants, respiratory care, and more. Every person will need a medical device at some point or ano...

If we were to compare ISO 9001 vs ISO 13485, which one should you adhere to?

As of February 2, 2026, the transition period for the Quality Management System Regulation (QMSR) has officially ended. The FDA now expects full compliance with this new framework, guaranteeing that FDA 21 CFR part 820 and ISO 13485 operate as one.

In addition to meeting rigorous safety requirements, medical device manufacturers must also comply with strict quality standards. That is why a compliant Quality Management System (QMS) is fundamental to any Life Sciences company operating in the tig...

In the life science industry, the race is on to earn the prestigious ISO 13485 certification as soon as possible, since it prepares companies for the future EU MDR audit. If you're in the life science industry and after the ISO 13485 certification, t...