Question
Under the European Regulation there are many cosmetic products with very low amounts of acidic components (such as glycolic acid, trichloroacetic acid, salicylic acid, lactic acid, etc).Active ingredients in higher concentrations (such as in the case...
Any Steve Martin fans out there? How about Ant Man and the Wasp? No? Then how about Carsten Horn, the business development manager for maxon precision motors? Carsten gave a 10x Medical Device talk on product design and manufacturing considerations w...
Barbara Duffy, DHSc, MPH, CPHQ, LHRM, RN
Chief Operations Officer for Healthcare Innovations Institute (Hii)
October 2018
My group is making realistic, full-sized, medical models that provide a high-fidelity surgical experience.Used for medical schools' education and training, these durable, soft, silicone models can mimic nearly any organ or system (including normal, d...
I'm new to my orthopedic implants and associated instrument company and inherited a 510(k) in review. In this 510(k) and those cleared in the last year, we had no discussion on usability 62366-1. We also didn't discuss evidence for biocompatibility b...
Long-time readers won't be surprised that my dear friend, regulatory expert Robert Packard is offering to teach an FDA pre-submission workshop for free. In fact, the last time we held this workshop – some 3½ years ago – more than 1,500 members regist...
Hi Everyone, We're new to the FDA medical device, and we're looking to implement an eQMS system into our workflow. We've looked at Greenlight Guru, MasterControl, and Enzyme. Was hoping to get some feedback from the folks here regarding the pros/cons...
Clément Vallois
Project leader - Medical devices development guided by user satisfaction and patient safety
October 2018
Dear colleagues, what are your "tips and tricks" to limit the number of article codes for your finished products?How do you manage the different power cords, languages for software interface, languages for IFU, duration for authorization time, labeli...
“Let's forget about how many of you have invested in Bitcoin. How many have just heard of Bitcoin or blockchain?” began Jad Mubaslat, founder of Bitquick, and Industrial and Human Factors engineer. “How many of you understand it?” he continued. (Not ...
There are many resources available on QSR, design controls and standards, etc; but there is a gap in understanding how these protocols should be designed to follow these regulations.Let’s say I am designing a PCB and have to write a protocol to test ...
I just came across a legal manufacturer in EU with CE Certificate granted to their devices but without having ISO13485 certificate.I ran through MDD 93/42/EEC and it seems there is no stated requirement that a legal manufacturer needs to obtain certi...
