Scilife Blog

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...

It’s that time of the year - it’s time to plan your conference calendar for 2025! As always, we’re here to help you get an overview of everything that’s happening in the medical device industry this year and there should be plenty of opportunities to...

Like any other regulated product, your medical device must be properly labeled. But do you know how to prepare a medical device label and which regulations your label has to comply with? And how about which ISO standards can help you meet these regul...

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...

No doubt the world has changed in recent years. Yet innovation in the medical field is stronger than ever.

Are you worried about writing a change control document for organization-wide change? It’s normal that this can feel like a gut-wrenching process sometimes. After all, change management is no easy task! The bigger the organization, the more arduous t...

Recently, our Scilife CEO Filip invited Mika Siitonen, Medical Development Manager at Labquality and seasoned expert in medical device regulatory guidelines, to answer anything and everything you wanted to know about performing Risk Management under ...