In projects related to medical devices, operations are executed based on ISO 13485—a quality management system (QMS) certificate. Here, a practitioner shares his design philosophy for setting up a QMS for a MedTech startup.
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The trade-off between project delivery time and quality often depends on the specific requirements and constraints of the project, but this is not always something that’s properly assessed. When push comes to shove and you have to decide, which side should you pick?
This article draws on well-known, basic project management concepts to introduce the high-level project management concepts of defined and empirical process control. It also attempts to contrast them and suggest how they might be used by PMPs in practice.
Due to the nature of the regulatory landscape and the complexity of the healthcare system, MedTech startups experience a higher level of uncertainty and risk. This PM shares his first-hand experiences from a startup launch in this sector.
When project teams are buried in the details of their work, it’s easy for them to forget that they are producing solutions for real people. PMs need to help them remember.
Test-driven development is an important part of ensuring that software can be effectively evaluated before it is deployed to embedded systems. Program managers must be prepared to accommodate additional test time—and champion the creation and maintenance of custom test platforms and tools.
Managing a capital project is not for the faint of heart. Navigating the complex web of planning and execution requires an understanding of many aspects in the project delivery lifecycle. One key approach for PMs is to focus on achieving operational readiness once the project is complete.
The growth of agile and the increasing pace of all forms of project delivery have meant that the triple constraint is no longer the thing we all have to tattoo on our brains. But it is still important, and it is still heavily misunderstood. If it’s not helping, then it needs to adapt—and a new variable can help.
Accreditation offers periodic self-evaluation, assessment and improvement opportunities for the educational institution. Higher education institutions should handle accreditation projects with utmost care—and use it as a chance to refine their plans to offer the best services for their students and community.
If what we measure prompts change, then we have to be careful what we evaluate so that attention is focused on those things that are most meaningful and important. We are exhorted to “measure what matters” with “key performance indicators"—which often miss the mark.