I think it's true that focusing too much on just meeting regulatory requirements can limit the full potential of quality management. Regulations are important for safety and consistency, but they’re o...

I recently came across the 2019 recall of Allergan's BIOCELL textured breast implants. The FDA requested this recall after data linked these implants to a rare cancer called Breast Implant-Associated ...

Effectively communicating the trade-offs between time compression methods like crashing and fast tracking, and the risks they pose to cost and qualit, requires project managers to be both strategic an...

Using procurement as leverage to encourage suppliers to adopt environmental and social policies can be ethical and effective when handled responsibly. The key is balance, ensuring transparency, fairne...

Project management software significantly simplifies and enhances the accuracy of project planning and execution. While these tools do not fully automate setting dates and budgets without human oversi...

In 2015, Medtronic encountered major regulatory trouble over its SynchroMed II Implantable Infusion Pump. After nearly a decade of inspection findings, the FDA concluded that Medtronic repeatedly fail...

When managing medical device projects, understanding where our project stands in terms of schedule and budget is important. This is where Schedule Variance (SV) and Cost Variance (CV) come into play, ...

Hello everyone, in the complex world of project management, staying on budget while effectively tracking performance is paramount. Earned Value Management (EVM) is a powerful tool that addresses these...

In medical device projects, where precision and clarity are paramount, combining formal and informal communication methods often proves most effective. A strategic mix of these methods can address the...

To determine the ideal number of project update meetings, it’s important to consider the project's scope and the team's communication needs. A practical approach might be to use a flexible scheduling ...

When a customer requests changes after project execution has begun, a proactive and collaborative approach can effectively manage these changes while minimizing disruption. Firstly, I would suggest im...

Monitoring and controlling are important in running a project towards success, making sure it adheres to planned objectives related to scope, timeline, budget, and quality. While tools like earned val...

At the end of a project, having a "reflection session" can be very useful. In this session, the team can sit together in a relaxed setting and share what they think went well and what didn't. For inst...

Effective information distribution is a critical component of project management, particularly in how it influences productivity and clarity within a team. Striking the right balance between communica...

Navigating regulatory requirements is a critical challenge for companies in the medical device industry. These regulations are essential for ensuring that new devices are safe and effective before the...