The Design and Development Plan is a foundational blueprint that guides the medical device engineering process. By first setting clear objectives, the...

Design verification and design validation, though both integral parts of the PDCA cycle, serve distinct roles in medical device development. Verificat...

Transitioning into project management in the medical device industry blends technical acumen with strong organizational skills. A typical day involves...

A project manager’s ability to adapt goals while preventing scope creep also hinges on understanding the personal challenges team members may face. Im...

Balancing value between stakeholders and customers often hinges on project context, timelines, and long-term strategic goals. On one hand, prioritizin...

Regulatory risk is indeed a significant challenge in medical device project management. Even when the team has meticulously planned for FDA approvals,...

Project managers can cope with external risks, such as supplier delays or supply chain disruptions, by implementing proactive strategies and maintaini...

Incorporating new technologies into a project depends significantly on the stage of the project and requires careful evaluation to balance potential b...

When verification tests fail, the first step would be to distinguish between a test design issue and a device design issue. For example, a medical dev...

I’ve never experienced being a ring-fenced employee after a company was sold off, but it sounds like a bad situation. From what I understand, an advan...

Consulting and legal services are critical to the success of medical device companies, especially when navigating regulatory submissions. Regulatory c...

International contract law plays a critical role for medical device companies seeking to expand into foreign markets. These companies must navigate a ...

The sudden move to remote work during the COVID-19 pandemic introduced unique challenges and benefits that affected each organizational structure diff...

Organizational change in the context of functional, project-based, and matrix structures offers a range of benefits and challenges. Each structure has...

It seems that our project has naturally evolved into a matrix organizational structure, which brings a lot of flexibility and collaboration to our wor...