Organizational development (OD) serves as a critical enabler for medical device manufacturing companies to successfully integrate advanced technologies such as AI and IoT. Beyond fostering adaptabilit...

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 documented has the chance to be scrutinized and picked a...

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

Risk management is an evolving process that extends beyond compliance with ISO 14971 and encompasses a broader integration of proactive methodologies through a device's lifecycle. One important area n...

Coordinating risk evaluations with design verification and validation results to assess potential risks throughout the development process is incredibly important. Failure Modes and Effects Analysis (...

Great question Samiha! In my opinion, when transferring design control and standards to any contract manufacturer, especially in medical device production, companies must consider several critical iss...

The Design Transfer team ensures that all relevant design information is provided to production teams. They consolidate every critical detail, from material requirements to assembly instructions, and ...

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 Tolerance, and Experience with Regulatory Audits. In term...

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'd like to expand more on the disadvantages of movi...

A few more benefits of software validation include but are not limited to:Extended Device Longevity and Lower Maintenance Costs: Validated software is typically more stable and less prone to bugs or m...

Participating in a clinical trial is a meaningful way to contribute to the development of new treatments potentially shaping the future of medicine. Modern tools make it much easier to search for tria...

While clinical trials are critical for evaluating the safety and efficacy of a product, they often lack in participant diversity and the real-world complexity required to paint a full picture of produ...

Effective coordination and communication are essential when adverse events occur in clinical trials. Maintaining clarity between investigators, sponsors, IRBs and CROs is essential. In my opinion, usi...

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

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 can bring out when speaking with customers. I would...