Question
This 2016 article says the first causes the second: It blamed manufacturer risk management for a 2014 peak in recalls: The culture, the shallow industry-wide understanding, the inability to tie risk management into quality management systems. The aut...
Did you wait until the last minute to update your quality system procedures to the new ISO 13485:2016 standard?My team is helping 3 companies with this problem. One company is very large, with thousands of employees and multiple sites. Another compan...
"I find many device manufacturers fall short with their documentation," writes CEO Emanuel Weisgras, who answered my group invitation with expertise to share here. He writes, These five points may help you through regulatory and speed you to market. ...
Dorothy Erlanger
Healthcare industry expert |Compliance Metrics Master|Mindfulness/WellnessPro| Ironman Triathlete|International Speaker
April 2018
A National Law Review article raised three possible reasons - without drawing conclusions. Would be interested in perspective from execs in this group. Link is Main possibilities from their perspective: 1) agency is taking a different, more cooperati...
Hello Medical Devices Group,I'm an investor in a medical device start up and our Team is seeking an experienced marketing consultant. The patented device has two major features:1. Esophageal biopsy and, 2. Therapeutic drug delivery.We are on track fo...
Nersi Nazari, MDTX keynote speaker and CEO of VitalConnect, bet the fate of his company on the widespread adoption of continuous patient monitoring. Sounds like a reasonable bet to me. In his 40-minute keynote at https://medgroup.biz/Nazari (replay, ...
Looking to educate myself on LTAC facilities - who are the key decision makers and how open they are to new technologies. Anyone have insights they could share? Thank you!source: https://www.linkedin.com/groups/78665/78665-6390321518814990338
Question: Would an in-country representative / agent for a medical device manufacturer exporting (from USA) to a country - such as China - be responsible for compilation and submission of required documentation for device registration, or is that the...
I didn't count, but I was surprised how many 10x/MDTX speakers implored our medical device design, development, manufacturing, and commercialization guests to abide by the following rule: 👉 Consider every aspect of your new product development right ...
Most medical devices in the US today are marketed under the premarket notification 510(k) authorities of the U.S. Federal Food, Drug, and Cosmetic Act. In order to market some types of Class I and most types of Class II devices in the United States, ...
