Did you know the market for precision medicine is projected to more than triple by 2026? I'm not surprised by the growth rate given everything we're reading about personalized medicine. So I got to thinking: How would you regulate something like that...
As originally asked by
As originally asked by Giovanni Lauricella. The Medical Device Industry is certainly a global industry, but not equally successful around the world for numerous reasons. • Japan has a challenging/difficult regulatory system • Israel is known for heav...
President at Ombu Enterprises, LLC
In a Warning Letter to Anybattery, Inc. FDA says that replacement batteries are accessories, manufacturers must register and list, and provide a 510(k) or PMA supplements as appropriate to the device that uses the battery.In the recent draft guidance...
Bharath Balaji Sathiyamoorthy
I am concerned as an Engineer and as a common man about the accessibility which in turn depends on affordability of Medical Devices that we create. My limited knowledge tells me that the medical devices cost is so high that it becomes affordable only...
Last year I wrote a post entitled "When Abby died." It relayed how my unlucky friend Paul's daughter was the "one" of the estimated 4,500 children stricken with a fatal epileptic seizure, now almost 11 years ago. Knowing as little as I do about the d...
Ship & Print Your FDA eCopy
What is MIS?Everyone that is a member of this subgroup knows that the acronym for minimally invasive surgery is “MIS”. Initially this term had a narrow definition that referred to laparoscopic surgical techniques involving a laparoscope, ports (umbil...
Driving the business forward through culture change, Lean Six Sigma tools and techniques.
Does anyone know if there are any hard and fast rules around validation of a filling line used for dispensing medical diagnostic reagents. For example how many bottles should you test during PQ if your typical batch size is to be 5000?source: https:/...
Quality Assurance/ Warehouse Manager at The Cole Hair Transplant Group
You receive parts from a supplier. If those parts are made into subassembly at your location, you classify them as such. When the part is made at the supplier, it could one part or a subassembly. How do you classify as such into your system?source: h...
Principal Consultant at Class Three, LLC
I'm largely ignorant of how Class I devices get on the market and then what happens next. I typically work with Class III, and sometimes Class II. However, I've started running into early-phase start-ups with a basic technology that could be develope...