Last seen: Nov 5, 2024
It’s great to hear about everyone's audit experiences and insights on DHF, DMR, and DHR distinctions. I haven’t personally participated in an audit, b...
These insights highlight how vital validation is for ensuring that a product not only meets regulatory requirements but also truly serves user needs. ...
Great points on the role of risk management and documentation within design controls. Embedding risk assessments like FMEA into the design process def...
Multi-center trials definitely bring unique challenges, especially around maintaining consistency across sites. I agree that clear communication and s...
Patient safety and data integrity are at the heart of clinical trials, and guidelines like ICH and GCP provide a framework to ensure both. These stand...
Patient recruitment is a big hurdle in clinical trials, often causing delays and impacting study timelines. CRAs and CROs tackle this by using diverse...
These replies are great, and i’d also add that alignment between sales and marketing is key - when both teams collaborate effectively, the customer ex...
These are all great points, and I would add that medical device marketing also needs to focus on transparency and education. With technology evolving ...
If I were to create a company, it would focus on developing sustainable healthcare technologies, specifically affordable diagnostic devices for unders...
Both structures definitely have their pros and cons, and I think the choice really comes down to the business’s growth plans and funding needs. For sm...
These are all great points, and I’d also add that building strong relationships with customers, vendors, and partners plays a key role in long-term su...
These are great points. I’d just add that LLCs are usually the go-to for entrepreneurs because of their simplicity and flexibility, especially for ow...
Regulatory Affairs is an interesting field, and while I haven’t worked in it myself, I know that it plays a vital role in bridging the gap between com...
I agree that audits, both internal and external, play a crucial role in ensuring that QA and QC follow proper protocols. It"s interesting how QA is ob...
These are great points. I completely agree that having a diverse panel with a range of expertise is critical for thoroughly evaluating novel products....