Last seen: Feb 10, 2025
During verification testing, it is quite common to encounter unanticipated issues (like adhesive failure in water) that drive budget increases for add...
I believe the differences between project managers and program managers extend into both technical focus and soft skills. Project managers concentrate...
When determining the correct product code and regulation number, I think it's important to develop a detailed comparison. This tool helps align your d...
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 ...