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As the life sciences are digitalizing at an unprecedented scale and rate, data lifecycle management is becoming increasingly important. The two major factors driving this rapid and close-to-universal digitalization are Industry 4.0 and the ...

GMP stands for “Good Manufacturing Practices.”  While this concept may sound simple in theory, there’s quite a bit that goes into it. This piece will outline the five main components of GMP.

Defining Medical 3D Printing Simply put, 3D medical printing is the process of creating medical devices, transplants, surgical tools, and other medical products from a digital 3D model through additive manufacturing.

What actually makes a ‘good’ leader good, in a sector like the life sciences today? Leadership is not just a singular quality, of course. It’s the use of a whole rich skillset. The talent of being adept at multiple skills simultaneously. And not just...

Introduction to Audits An audit is the verification, inspection, or examination of a process, product, or system to guarantee compliance with regulatory or organizational requirements. The scope of an audit can apply to an entire organization or be l...

Medical Device Development Phases According to Regulations Medical device development is an inherently complex process with increasingly rigid requirements that must be met for FDA approval and/or EU MDR compliance.

QA and QC processes are inseparable parts of the overall Quality Management System (QMS), and they are often used interchangeably. However, while these processes feature some overlap, it’s essential to note that they are two separate entities and tak...