Scilife Blog

Ah, design verification—the unsung hero of medical device development. It’s the phase where we ask, “Did we build this thing right?” before moving on to validation, which asks, “Did we build the right thing?”

Medical device quality assurance can feel overwhelming, especially when you’re balancing product development, regulatory updates, and real-world patient safety. But the truth is, getting QA right is one of the most reliable ways to keep your product ...

Nobody said medical device design and development would be easy. The story goes… Pressured by deadlines, busy product and engineering teams jump straight into building their medical device.

In today’s fast-paced and tightly regulated medical device industry, a Quality Management System (QMS) is far more than a mere compliance exercise, especially for medical device manufacturers.

If you work in the medical device industry, you already know that medical device risk management is a part of the job from the very beginning. Whether you're bringing a new product to market or continuing with an existing one, the way you approach ri...

In the ever-evolving world of healthcare, Laboratory Developed Tests (LDTs) have emerged as critical tools for diagnosing a wide array of medical conditions. These tests, created and used by individual laboratories, are instrumental in everything fro...

Software as a Medical Device (SaMD) is a groundbreaking advancement in the healthcare industry, transforming the way medical care is delivered and managed. First developed in its earliest forms in the 1980s, this category of software operates indepen...

In life sciences, especially if you’re in the medical device industry it becomes harder to manage projects in accordance with your company’s quality management system. Companies design and/or develop products every day to improve their existing produ...

You’ve finally received your 510(k) clearance and feel ready to start commercialization in the US market. But how do you go about importing medical devices into the US? Importation is the final hurdle in an often year-long process to obtain regulator...

It is almost impossible to work in the medical device space without hearing the term ISO 13485. But what is it? And how can you avoid mistakes during scoping and implementation and ensure the continued availability of your products on the market? Tha...

The Internet of Medical Things (IoMT) is revolutionizing the MedTech industry by integrating medical devices, wearables, and health applications through Internet connectivity. This transformation enables continuous health monitoring, real-time data e...

Looking to get CE approval for medical devices? Navigating the regulatory landscape is essential for medical device manufacturers aiming to market their products in Europe. As one of the most important regulatory markets in the world, the EU stands a...