Scilife Blog

You’ve finally received your 510(k) clearance and feel ready to start commercialization in the US market. But how do you go about importing your medical devices into the US? Importation is the final hurdle in an often year-long process to obtain regu...

The Internet of Medical Things (IoMT) is revolutionizing the MedTech industry by integrating medical devices, wearables, and health applications through Internet connectivity. This transformation enables continuous health monitoring, real-time data e...

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 at the forefront of regulatory development and in...

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 medical device inspections is scary! But the management of FDA inspections for medical devices is a critical aspect of ensuring compliance with regulatory standards and maintaining the integrity of the medical...

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...

Quality management is the foundation of medical device manufacturing, as it interlinks with every aspect of the process, from design and development to post-market surveillance. Quality management systems (QMS) are deeply entrenched in the industry a...

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...