Question
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, ...
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...
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...
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 ...
What an awesome question. You only have 60 minutes to ask the FDA questions during a pre-submission meeting. Conventional wisdom is to spend 15 minutes with introductions, 30 minutes asking questions and finish with 15 minutes summarizing action item...
In October 2015 I recorded my first “Learning Lunch”, and the topic was “Getting the most out of pre-submission meetings.” One of the attendees asked, “Are pre-submission meetings mandatory for 510(k) submissions.” The answer was, and still is, no. H...
At my new job, I reviewed all the overly complex procedures for such a small company 5-8 employees. I'm overwhelmed. I need to simplify, revise, and implement easy to follow procedures quickly. My head is spinning. Does any one have any suggestions i...
