The initiation phase in medical device projects is crucial because it lays the foundation for everything that follows. Key inputs like feasibility stu...

Strict design controls are essential for ensuring safety and regulatory compliance, but they don’t have to stifle innovation. Companies can maintain f...

An organization’s culture and resources directly impact project execution by shaping how teams collaborate and make decisions. A company with a hierar...

A key way to strengthen verification strategies after a failure is to establish a structured feedback loop where testing outcomes directly inform futu...

Keeping the Design Input Document (DID) and Design Specification Document (DSD) separate helps ensure a smooth development process by allowing flexibi...

A key strategy for managing stakeholder expectations while staying within the project’s scope is to establish clear project boundaries from the beginn...

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 ...

Organizations can make PDCA an ongoing process by making small, frequent improvements instead of treating it as a one-time checklist. One way to do th...

Organizations can balance regulatory compliance and innovation by embedding Design Controls into their everyday workflow rather than treating them as ...