I recently experienced facing a regulatory change which affected the type of clinical testing and labeling for our products. The 2016 SMBG FDA Guidance made the packaging requirements more stringent f...

Sorry technical difficulties! Posted this out of order! This was meant to be after Ashley's post... This is a really good addition to the conversation Ashley. It seems like more innovation is with sta...

I agree with f-dot, I think there is a good purpose for this book to open people's eyes to the medical industry. If a company fails a clinical trial, the results still become public which can hurt tru...

I agree with ial4 and appreciate sharing the guidance for market approval/submission when there is a change in a medical device. Depending on the risk from the change being made and the classification...

Responding to one of bnb6's questions, I feel clinical trials (depending on the product and its intended market) are very expensive and can be very time consuming, but are critical in proving the qual...

I agree with hc225 that most countries adapt the structure of their plans from the standards written in ISO13485:2016. Medical products need to be of highest quality to deliver confidence and reliabil...

Acupuncture needles are regulated by the FDA, being classified as a Class II device. If the manufacturers of acupuncture needles claim treatments with their devices, then I believe the FDA would regul...

FDA 510(k) submissions are for class II devices that have already been approved in the market since the FDA passed the Medical Device Amendments Act in May 28th, 1976. When submitting a 510(k), the de...

Continuing from alexandrabuga's response, a Request for Designation is a written to the Office of Combination Products (OCP) requesting regulatory classification to determine if it is a device, drug, ...

I agree with your ideal skills, having a team that varies in their experience and background, works well together, and has a passion and drive in their efforts as a valuable team member. Reliability, ...

I believe this is a very good conversation in understanding that different cultures can be seen in project management. What I have understood from experience of myself and friends is that management p...

In response to the experience seen in industry, I have similar input as hruship101 and srg36. Working for a global SMBG company, validation and verification (V&V) is understood to be our leading f...