Cost estimation in medical device projects is challenging because many factors can change unexpectedly. A major issue is estimating costs before fully defining tasks, which can lead to missing key exp...

One of the biggest challenges in project initiation is ensuring that the Project Proposal is clear, realistic, and aligned with business and regulatory requirements. A poorly defined proposal can lead...

A Work Breakdown Structure (WBS) simplifies project planning by breaking a large, complex project into smaller, more manageable parts. This allows teams to clearly see each task, who is responsible fo...

The initiation phase in medical device projects is crucial because it lays the foundation for everything that follows. Key inputs like feasibility studies and regulatory assessments help determine whe...

Strict design controls are essential for ensuring safety and regulatory compliance, but they don’t have to stifle innovation. Companies can maintain flexibility by integrating early prototyping and pa...

An organization’s culture and resources directly impact project execution by shaping how teams collaborate and make decisions. A company with a hierarchical structure may struggle with slow approvals,...

When a product fails verification, the immediate reaction is often to assume a fundamental flaw in the design or materials. However, in many cases, the testing conditions themselves may need reevaluat...

A key way to strengthen verification strategies after a failure is to establish a structured feedback loop where testing outcomes directly inform future design and risk management processes. When a fa...

Keeping the Design Input Document (DID) and Design Specification Document (DSD) separate helps ensure a smooth development process by allowing flexibility and better organization. The DID acts as a fo...

A key strategy for managing stakeholder expectations while staying within the project’s scope is to establish clear project boundaries from the beginning. When verification failures occur, it’s crucia...

One of the biggest challenges in medical device development is ensuring that design flaws are caught early enough to prevent costly rework or safety risks. When design reviews are conducted too infreq...

One of the biggest challenges in medical device development is handling design change requests without causing delays, confusion, or regulatory issues. Design changes can come from new regulatory requ...

One major challenge with the Humanitarian Device Exemption (HDE) is the balance between access and safety. Since these devices don’t have to meet the same level of clinical effectiveness as other Clas...

A common challenge in medical device development is creating a Design Development Plan (DDP) that is both comprehensive and flexible. The DDP serves as the foundation for the entire project, outlining...

A major challenge in medical device development is ensuring that all design decisions, changes, and testing results are well-documented to meet regulatory requirements. The Design History File (DHF) s...