Scilife Blog

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...

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 ...

How much do you know about Medical Device Coordination Group Documents? You may be more familiar with their abbreviation: MDCG. Developed on behalf of the European Commission, MDCG Documents are designed to help manufacturers understand how the Medic...

In the medical device industry, there are tons of abbreviations. And as a medical device professional you can easily get lost in this acronym ocean! The most important (and most confusing) abbreviations are DHF, DMR, and DHR. These three abbreviation...