Question
My company services Clinical pathology equipment. i.e. microtomes Cryostats Tissue process, stainer, embedders etc. Since theya re not directly hooked to the patient I believe they are class 2 devices. We are exploring doing AC leakage testing on the...
What is the ROI on products that are outsourced, depending on the products, and removal of head count when you can eliminate people in mfg by outsourcing?source: https://www.linkedin.com/groups/78665/78665-6007319912278736900
I called best-selling author Terry Grossman, M.D. (Baby Boomer's Guide to Living Forever) last week because we're both speaking at BRINK 2015 on June 5. See http://medgroup.biz/BRINK2015 to join us in Palm Springs, California. (It's very reasonably p...
As originally shared by John Eckberg Senate Finance Committee Hears Industry Testimony On Impact Of Medical Device Tax A top executive of medical device manufacturer B. Braun Medical Inc. recently told U.S. senators that the medical device tax should...
Often I see companies performing design verification by manufacturing components, subassemblies, etc. and performing inspections and tests. In these instances, it appears to me that some device manufacturers have conflated design verification with ma...
My company is a manufacturer of Customised Procedure Packs (CPP's) and we need to prepare clinical evidence in regard to these packs. Apart from literature reviews, does anyone have any suggestions on how to obtain the appropriate evidence to meet TG...
Can someone please clarify?If a product is classed as exempt ie (Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 872.9. If the device i...
As originally asked by
Long-time readers won't be surprised that 13485-expert Robert Packard's workshop at the 10x Conference was standing room only. Or that he offered to teach his class for free. Register at http://medgroup.biz/510k-tips for Rob's free workshop on how to...
Correct me if I'm wrong, but both OEMs and contract manufacturers are feeling strain from industry reform. This reform seems to be leading to higher regulation requirements being passed onto OEM suppliers. So with more regulatory and more demand for ...
