Bioequivalence and Bioavailability Forum

manan ☆ Ahmedabad, 2011-03-31 08:56 (5569 d 06:17 ago) Posting: # 6841 Views: 5,952	Medical Devices [Off Topic] Post reply
	Dear all This is a bit out of the topic discussion. I would like to know your ideas about Regulatory Guidances for Medical Devices. We have been hearing much more about drugs. But can anyone let me know how far and good is the Regulatory applications for Medical Devices. Your views will be helpful. Thank you Edit: Category changed. [Helmut]

Coja66 ☆ 2011-03-31 17:07 (5568 d 22:06 ago) @ manan Posting: # 6844 Views: 4,746	Medical Devices Post reply
	Hi Manan, IMHO there are several guidelines available (e.g. WHO, FDA), and I think they are pretty good. However, they are less developed as compared to guidelines on medications, as medical devices is a newer field. At my company we tend to handle 'uncertain'/'not-handled' situations in the general GCP manner, and write a note-to-file. Not sure if this answers your question

Medical Devices [Off Topic]