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.
Given that 90% of his career has been in the private sector, this practitioner's approach is very much from a business perspective. How would that translate in his role as an elected official in his local community?
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.
Question: I was just offered a promotion to Compliance Officer and it comes with a substantial pay raise. The only problem? I don’t really know what that is or what I would be asked to do—we’ve never had this position before. Is it possible to take the job and figure it out along the way?
Having a long-term vision and strong project management is essential for nations to develop. However, only a handful of countries have been successful at it. Here we examine some that have embraced a visionary approach—and why others haven't.
The PMP offers a host of benefits for service members, and transfers with them to the civilian workforce. This article advocates for service members to pursue the certification and explains some of the benefits that the military offers to help achieve this goal.
What many hoped would be a field of dreams in a local community turned into a field of reams after backlash from the public due to poor communications. How can you turn this foul ball of a public sector project into a home run?
There are several things you can do when presented with development requirements that either don’t seem appropriate for your project—or that present unintended consequences for the often unique, typically very custom projects that public project managers are regularly assigned.
Regulatory impact assessment (RIA) is widely adopted as a global practice when developing new legislation and regulation. The RIA is all about what should happen. Project management is all about what does happen. Understanding RIA can benefit project managers who are enlisted to successfully realize the RIA recommendations.
The benefits of project management for traditional energy projects, such as building a power plant, are well known. But there are also benefits for energy sector reform, particularly government initiatives. Project management techniques can help by clarifying objectives, engaging stakeholders, improving the speed of legislation, and managing scope and schedule.