Scilife Blog

Looking to get CE approval for medical devices? Navigating the regulatory landscape is essential for medical device manufacturers aiming to market their products in Europe. As one of the most important regulatory markets in the world, the EU stands a...

Keeping track of medical devices is paramount to ensure the safety of patients. Traceability allows manufacturers to identify, trace, and control medical devices and is necessary for several reasons, chief among them regulatory compliance.

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...

The hype of artificial intelligence (AI) is revolutionizing industries such as pharmaceuticals and medical devices.

The world of medical devices is steeped in regulations - you can't say medical devices without saying compliance. In this world of medical device regulations, compliance is critical. It ensures the safety and efficacy of products entering the market ...

While sometimes deprioritized, regulatory compliance is critical for medical device manufacturers. And among the global regulatory frameworks, the Medical Device Single Audit Program (MDSAP) has gained prominence over the past decade. MDSAP is a comp...

Having the FDA knocking on your door for a medical device inspection is scary! However, the management of FDA inspections for medical devices is a critical aspect of ensuring compliance with regulatory standards and maintaining the integrity of the m...

The United States Food and Drug Administration (FDA) is the regulatory body responsible for the safety and efficacy of medical devices in the United States. The 510(k) clearance is their classic premarket clearance for Class II medical devices that m...

When producing medical devices, it’s important to have a robust Quality Management System (QMS) in place to ensure that devices are developed and consistently produced in line with the relevant quality standards in each market. To do this, you need t...

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...

Developing and bringing a medical device to market is a scary process. Not only do you have to come up with a great idea or design improvement and develop a working prototype, but you must also ensure the device is safe and performs as intended in an...

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