Scilife Blog

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 year again! The time to start planning your conference calendar for 2026. As always, we’re here to help you navigate what’s ahead in the medical device industry, with plenty of opportunities to get inspired, exchange ideas, and take...

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 ...

A fundamental part of safeguarding patients in Europe comes from ensuring that medical devices and in vitro diagnostics (IVDs) meet consistent, high regulatory standards. Under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation...

In the medical device industry, there are tons of abbreviations. And as a medical device professional in the US working with Quality Management Systems Regulations (QMSR), or 21 CFR Part 820 as it’s technically known, you can easily get lost in this ...

The EU medical device regulatory framework continues to evolve. As EUDAMED modules roll out and MDR timelines shift, many manufacturers are finding that maintaining compliance now requires far more structure and oversight than it did just a few years...

The medical device lifecycle is an inherently complex process with increasingly rigid requirements that must be met for FDA approval (21 CFR Part 820) and/or EU MDR compliance.

Staying ahead of industry shifts has never been more critical for anyone working in biotech, pharma, or MedTech. The pace of innovation is accelerating, regulatory expectations are tightening, and AI is reshaping everything from discovery to commerci...