Title 21 CFR Part 11: FDA Requirements Explained

The FDA’s Title 21 CFR Part 11 regulation governs the way life sciences organizations are permitted to use electronic records and e-signatures in the place of, or in addition to, paper records. Let’s take a look at the requirements of this…

Making the Case for ALM in Pharma Project Management

Germany to Take a Pioneering Role in Self-driving. But Can Regulators Catch Up?

How Over-The-Air Updates Are Turning the Auto Industry Upside Down

Legacy Software Pains in the Development of Technology Products

Safety First: 5 Top Tips for Medical Device Compliance in 2021

Is the complexity of achieving medical device compliance keeping you up at night? Losing sleep over patient safety concerns? It’s no wonder. You’re in the business of developing medtech that has the potential to save lives…

Agile Risk Management in Digital Safety-critical Product Development

Automotive Disruptors: Innovative Players Driving Change in the Mobility Sector

Disruption has become a trope in most recent analysis about the automotive industry. But what companies are driving that changes, and how are they expected to transform the sector?