Scilife Blog

If you’ve worked in medical devices for a while, the term Device Master Record or DMR probably feels like muscle memory. It’s been part of the regulatory vocabulary for decades, especially if you’ve worked with U.S. Food and Drug Administration (FDA)...

In the medical devices industry, “design transfer” refers to the process of transitioning a medical device from development to large-scale manufacturing. For manufacturers, particularly personnel in the quality, R&D, and manufacturing functions, ...

In 2026, the life sciences sector operates in a state of high-precision oversight, where even the most established partnerships require constant, data-driven verification. I recall a situation involving a critical component manufacturer who had maint...

Most companies think quality is a cost. In reality, poor quality is the actual expense. In the pharmaceutical industry, poor quality comes with a significant and measurable cost. It can range between 15% and 40% of total sales revenue, as found by di...

If you’re here, chances are you’re considering, or already actively searching for, a knowledgeable life sciences consultant to help pave the way for your organization’s future growth. Maybe you need support achieving ISO 13485 certification, obtainin...

SharePoint has become an accidental QMS for many life sciences organizations. And look, we get it. It’s “free” (or at least already included in your Microsoft 365 subscription), it lets you build folder structures, and you can organize quality docume...

If you work QARA in medical devices or pharma, you know that CAPAs aren’t just paperwork - they’re at the heart of compliance and audits. That said, writing CAPA reports that hold up under inspection can be tricky.

If you work in medical devices in the EU, the question is no longer what EUDAMED is, but whether your data and ownership model will survive mandatory use.

Corrective and Preventive action (CAPA) sits at the core of every quality system in the life sciences. When a deviation appears, a complaint escalates, or an auditor asks an uncomfortable question, your CAPA process ultimately decides the outcome.

Any QA professional in life sciences who has ever prepared an annual product quality review knows how demanding it can be. What should be a structured quality exercise often turns into weeks of pulling information from everywhere—spreadsheets, emails...

Switching from paper to eQMS creates the perfect opportunity for QA teams to build on what already works and streamline what doesn’t.

Medical device teams often spend months perfecting a breakthrough design. But the moment ISO 13485 certification and compliance enter the picture, momentum often grinds to a halt. The quality team has been brought in too late. Documents are scattered...