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 (FMEAs) and Hazard Analysis are two commonly used techniques that help with assessing these risks….   Read more»

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 issues or limitations to ensure compliance and quality. First, quality control consistency is critical….   Read more»

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 act as a single source of information for production teams to refer to….   Read more»

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 terms of regulatory strategy and risk tolerance, some…   Read more»

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 moving target success criteria. For one thing, moving…   Read more»

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 malfunctions, reducing the need for frequent updates and repairs….   Read more»

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 trials near your location, learn about the study…   Read more»

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 product performance. Some specific issues or trends not seen…   Read more»

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, using a hybrid approach would be effective. Combining standardized protocols with some flexibility for…   Read more»

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 chain. Sourcing materials from multiple locations helps to mitigate the risk…   Read more»

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 argue, however,…   Read more»

I think the answer to this question is really based on where you want your career to end up. I have always been interested in people management. Before starting my graduate studies, I was torn between trying to attain my…   Read more»

When deciding between going with an S-Corp or C-Corp structure, one must carefully weigh the benefits of tax savings against broader opportunities such as raising capital and attracting investors. As mentioned, S-Corps have flow-through taxation. Basically, their income is only…   Read more»

Regulatory agencies such as the FDA and EMA, while governmental agencies, tend to operate similarly to non-profit organizations. They do not generate their own profit. Instead, they focus on providing the public service of ensuring that medical products are safe…   Read more»

I think this is a great topic to dive deeper into! I have experience in both, working in a research lab during my undergraduate studies and the corporate lab space in my professional career. I absolutely agree that research labs…   Read more»

I had a role in a Performance Evaluation R&D Group during one of my Co-Ops. Although this role was in the R&D field, being performance evaluation, we had a large role to play in the quality assurance process. We followed…   Read more»

Cybersecurity is certainly a vital consideration when migrating from paper-based to digital systems. Along with cybersecurity, another important factor to consider is data integrity. QA and QC departments must ensure that the integrity of data during migration remains sound. This…   Read more»

Regulatory Affairs is a great field to explore. From my own industry experience and from speaking with hiring managers, there is always a high need for employees knowledgeable about the regulatory process. I’ve personally been involved in a few Corrective…   Read more»

I think post-market management may have a more significant long-term impact compared to product development. While both play important roles in projects, the main focus of product development is meeting regulatory standards and checking device safety and efficacy. While this…   Read more»

You did a great job summarizing the FDA and CDRH’s role in regulating medical devices. It is also worth mentioning that the approval process for Class II and III devices is much more involved because of their higher associated risks….   Read more»