Question
I need the group's help in recommending a few books that describe the FDA medical device regulation process as basic introductory to intermediate level of material. I have done an Amazon search, but I didn't find very convincing options.source: https...
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...
I'm looking for recommendations on which certification and/or professional association would be best for strengthening my skills in auditing, statistical process control, and general quality and compliance issues. Any thoughts? ASQ? RAPS? CMQ/OE? Six...
The example provided in the Practical Guide for the implementation of a “risk-based approach” contains a single, one-paragraph example outlines three steps:• SWOT “review your QMS to improve or verify compliance.” Back in my day, we called this an in...
To ring in the new year, https://medgroup.biz/pre510k. This is a three-hour replay and the 108 slides from David Amor and Jon Speer's presentation at last year's 10x Medical Device Conference. We're making them available this week for $59 (guests pai...
I have just released the second post in the series “The Practical Guide to the ISO 13485:2016 Practical Guide.” This post explores insights from the Practical Guide on “risk-based approach,” the varying terminology used to reference it, and the QMS p...
New FDA data continues to show an industry in crisis. One third (1/3) of all site inspections still get CAPAs that are voluntary or official actions. This holds true going back to 2009. See the chart below. Note the black line that holds steady as th...
Even though the Corrective and Preventive Action (CAPA) process is at the heart of any quality management system, CAPA violations are the most frequently observed Quality System subsystem cited by FDA. It happens year after year – and regardless of t...
