Question
ISO, the International Standards Organization, tells us risk-based changes to the ISO 13485 standard are "to be published by the end of 2015." The new 13485 will build upon principles laid out in ISO 14971, the current risk management standard for me...
Roberta Goode
President at Goode Compliance International: Experts in Process Validation and FDA Compliance
September 2015
Why do customer complaints nonconformances continue to escalate to WLs and 483s at an alarming rate? Has something changed in the way companies are (mis)interpreting the regs, or is it more subtle? I'm curious to know what the group members think.sou...
I'm reaching out to others who have worked with and/or supplied to the Medical Incubator community. What is the best process for getting integrated as a supplier within the community? How does one get on an incubator AVL list or an incubator supplier...
I am particularly interested to learn whether anyone in this group has tackled the challenge of (or is aware of) any new point of care devices that are able to diagnose tuberculosis (in particular, multi-drug-resistant tb) in a way that is more effic...
When a medical device is being developed, per the FDA, a DMR and a DHR has to be created. The Quality System Regulation call DMR as Device Master Record and DHR as Device History Record. I saw in one set of documentation that the D in both DMR and DH...
Hello everyone, I am looking for standards related to wireless in medical devices. Any advice?Thanks a lotsource: https://www.linkedin.com/groups/78665/78665-6039440149673230339
A group member recently asked, "Where can I find companies with new medical devices or procedures or new products and who want to come to markets in SE Asia, Australia, Europe and Israel. Companies in US or Canada?" How would you advise him? Barry Kr...
Startups are competing to create the next Uber for healthcare. The industry is adapting to the new "sharing economy" and makes use of new technology to provide non-emergency house-call services. Heal, in the LA and Orange County area, promises to get...
As originally asked by
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...
