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Standard operating procedures (SOPs) describe, well, the standard operating procedures of a company. They provide step-by-step instructions on how to perform the most common tasks at a company. When SOPs are efficient, they decrease miscommunication ...

The FDA is transitioning from Computer System Validation (CSV) to Computer Software Assurance (CSA) for computers and automated data processing systems used as part of medical device production or medical device quality systems. So, what is the diffe...

Quality risk management is a non-negotiable requirement to comply with ISO 13485 and 21 CFR 820. Yet, every year, Life Sciences companies face warnings from regulatory bodies, such as the FDA in the U.S., the EMA in Europe and MHRA in the U.K. Warnin...

In May 2017, Life Science organizations were hit by one of the biggest cybersecurity incidents - the WannaCry ransomware attack. WannaCry spread rapidly across networks, encrypting files and demanding ransom payments in Bitcoin to decrypt them. The U...

Even an organization with stellar leadership and a solid core of employees experiences hiccups from time to time. Despite having assembled all the ingredients for a great organizational culture or a superior product, a company or department is not li...

Healthcare faces complex challenges in a world that is becoming more digital day-to-day. It has become clear that healthcare companies will need to embrace open systems that allow for the sophisticated analysis of multiple data streams and the develo...

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...

Artificial intelligence (AI) and machine learning (ML) are on the verge of transforming healthcare by creating new, vital insights from the vast amount of data gathered during healthcare delivery activities every day. AI/ML-based life science innovat...

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...

We wouldn’t be where we are today if it weren’t for the countless scientific discoveries made by pioneering women from around the globe. Their tireless efforts and groundbreaking work have, without exaggeration, saved millions of lives. When it comes...

Life science companies, including pharma, biotech, and medical device companies, churn out tens of terabytes of data every single day. That’s about the data equivalent of 5 billion pages of text. Every twenty-four hours! What’s more, data output per ...

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