Posts by Martine Janicki

Martine Janicki

ISO 21500 and Medical Device Development

The first edition of ISO 21500 Guidance on Project Management was published in September.  Prior to the publication of ISO 21500, project management practice was guided by the Project Management Institute (PMI®), an international not-for-profit professional association with over 700,000 members and volunteers advocating for the project management profession and responsible for the project management […]

Martine Janicki

How a Project Management Office (PMO) Helps Effective Medical Device Development

The term “PMO” (Project Management Office) appears ever more frequently in engineering firms, but is still not well understood. So what is a PMO, how do they impact medical device development, and what does the PMO look like at StarFish? In other words, why bother? For organizations that do not use a PMO, there are […]

Martine Janicki

Teamwork in Medical Device Development

What makes a project successful or not? A seasoned project manager, charismatic leader, low risk technology, spin on existing proven technology or the right discipline resource mix? Well, maybe it’s all of those and a bit of chance, but it’s most importantly the right attitude. Let me elaborate. In my last blog, I covered the […]

Martine Janicki

Winning Project Management Practices for Medical Device Development

In my last blog, I talked about risk management, extreme risk management from the device perspective, manufacturing perspective and project management perspective. Through the risk planning, risk engagement itself and mitigation implementation, I have learned that it is very important to communicate to team members, project owner and any other important stakeholders. Managing the expectations […]

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