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311 items found

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3 Tips for Quality Management System Setup in a Medtech Startup

by Edmund Shao

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.

Deliver on Time, or Deliver With Quality?

by Arturo Wishlitzky

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?

Defined vs. Empirical Process Control: Choosing the Best Approach

by Barry Milteer

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.

PM Lessons Learned From a MedTech Startup Company Launch

by Edmund Shao

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.

Remember: Users Are Real People

by Andy Jordan

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.

The Unique Challenges of Test-Driven Design (TDD) for Embedded Systems

by Steven Swiss

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.

The Triple Constraint, 2022 Style

by Andy Jordan

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.

5 Lessons Learned to Strengthen Accreditation

by Sarosh Azhar

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.

What Matters Won’t Measure

by Mark Mullaly, Ph.D., PMP

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.

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