Organizational development (OD) serves as a critical enabler for medical device manufacturing companies to successfully integrate advanced technologie...

I've personally been involved in a CAPA after a few audit findings. First of all, audits are grueling! Any and all paperwork that has ever been docume...

I agree that risk avoidance is a foundational strategy in the manufacturing process, but it must also be complemented by mitigation efforts and risk a...

Risk management is an evolving process that extends beyond compliance with ISO 14971 and encompasses a broader integration of proactive methodologies ...

Coordinating risk evaluations with design verification and validation results to assess potential risks throughout the development process is incredib...

Great question Samiha! In my opinion, when transferring design control and standards to any contract manufacturer, especially in medical device prod...

The Design Transfer team ensures that all relevant design information is provided to production teams. They consolidate every critical detail, from ma...

There are many factors that go into deciding how to interpret these guidelines. A few that I can think of include Regulatory Strategy and Risk Toleran...

I think that the steps taken to define success criteria have been more or less clearly represented by previous responses in this discussion thread. I'...

A few more benefits of software validation include but are not limited to:Extended Device Longevity and Lower Maintenance Costs: Validated software is...

Participating in a clinical trial is a meaningful way to contribute to the development of new treatments potentially shaping the future of medicine. M...

While clinical trials are critical for evaluating the safety and efficacy of a product, they often lack in participant diversity and the real-world co...

Effective coordination and communication are essential when adverse events occur in clinical trials. Maintaining clarity between investigators, sponso...

Contingency plans are certainly important for companies to avoid being affected by external factors. Specifically in terms of weather, it is important...

I certainly agree that it depends on the type of person you are. To be successful in sales, there has to be some sort of extroverted nature that you c...