Part 3 – now let’s introduce regulation First part of this, is let’s define “regulation” in context. Specifically, I’m referring to ISO 13485, EU medical devices (GMP, or “Good Manufacturing Practice”), and FDA medical device standards. Let’s also be clear, these aren’t just “guidelines” (insert Barbarossa quote here), they’re law. As law, what is their […]
Tag Archives: management
Leadership of IT/Software Teams in a Regulatory Environment
Part 2 – How Does This Apply to IT? All right, so we’ve laid out what it means to be a leader – but how does this apply to IT? At this stage we have to look at what it means to work in an IT environment – and there are some wildly different attitudes […]
Leadership of IT/Software Teams in a Regulatory Environment
Leadership of IT/Software Teams in a Regulatory Environment Thomas Theobald Part 1 – What Exactly Is “Leadership”? leadership /ˈliːdəʃɪp/ noun “the action of leading a group of people or an organization, or the ability to do this.” Not exactly helpful, are they? Wikipedia is slightly better: “is a formal or informal contextually rooted and goal-influencing […]