Scilife Blog

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...

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...

ISO standards are some of the most recognized global harmonized standards currently at work, along with the standards issued by IEC.

Medical devices have one purpose: to improve the life of patients. They are developed with this purpose in mind, and the entirety of regulatory compliance is designed to ensure that medical devices remain safe and perform as intended throughout their...

Any medical device manufacturer developing new products comes across design verification and validation. They are essential stages during the design control of a new medical device. Design controls are a series of steps and processes during the devel...

With the European Medical Device Regulation (EU MDR, 2017/745), the Unique Device Identifier (UDI) became mandatory for medical device manufacturers in the European Union. The MDR aligned the EU with the US market, where the UDI system had already be...

The US FDA (Food and Drug Administration) is known for many things. However, adaptability and the willingness to harmonize with other regulatory agencies worldwide might not be one of them. Nevertheless, in 2018 the FDA began work to reconcile the US...

When the updated European Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostic Regulation (IVDR, 2017/746) were issued in 2017, the European Commission increased the requirements for monitoring the behavior of medical devices in the mark...

Quality Assurance (QA) is an essential process in Life Sciences organizations, regardless of their size. It involves ensuring that products, services, and processes meet specific standards, and regulations, and meet the needs and expectations of cust...

2023 is almost up and it’s time to plan for 2024. With the number of innovations and news happening in the medical device industry right now, there should be plenty of opportunities to be inspired and participate in fruitful discussions in upcoming e...