I recently experienced facing a regulatory change which affected the type of clinical testing and labeling for our products. The 2016 SMBG FDA Guidanc...

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 conversatio...

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, ...

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...

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 ti...

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 ...

Acupuncture needles are regulated by the FDA, being classified as a Class II device. If the manufacturers of acupuncture needles claim treatments with...

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 i...

Continuing from alexandrabuga's response, a Request for Designation is a written to the Office of Combination Products (OCP) requesting regulatory cla...

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 thei...

I believe this is a very good conversation in understanding that different cultures can be seen in project management. What I have understood from exp...

In response to the experience seen in industry, I have similar input as hruship101 and srg36. Working for a global SMBG company, validation and verifi...