Question
If you do business in Europe, I heartily suggest you familiarize yourself – and quickly – with the changes in MDR 2017/745 and MDR 2017/746. See http://bit.ly/EU-MDR-Labelling-Compliance The EU Medical Device Regulation (MDR 2017/745 & MDR 2017/746) ...
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...
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...
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...
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, ...
I was not completely aware to Medicare & Medicaid Services (CMS) agency. It regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments and approve Laboratory Developed...
Dear all,does anyone has insights into the interpretation of Article 45 of the MDR (Article 41 in the IVDR). It sais that as part of the market surveillance activities, there is a change that the competent auhorities will review the technical documen...
Kris Kelly
Software Quality Assurance & Testing * SDLC Process Improvement * Regulatory Guidance * System Performance Scaling
February 2018
I posted a common sense article about "Recurring" Medical Device Recalls last week - then today I read this article in the Star Tribune:Dozens of U.S. patients may have to undergo surgery to replace their Medtronic heart defibrillators following the ...
Most 510(k) submissions are Traditional 510(k) submissions. However, once you already have 510(k) clearance for your device, you still need to obtain FDA clearance for significant changes to the device. Approximately 10% of the submissions are Specia...
