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    Hasit Seth
    Advocate-Counsel at Bombay High Court - India
    February 2018
    Hello...A Query About Books on FDA regulation of Medical Devices
    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...
    Rob Packard
    Ship & Print Your FDA eCopy
    February 2018
    What is the most efficient use of time during a pre-submission meeting?
    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...
    Rob Packard
    Ship & Print Your FDA eCopy
    February 2018
    Is a 510(k) pre-submission meeting required?
    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...
    Dinarie Correa, MBA
    Manager, QA/RA at VascuTech Medical
    January 2018
    please help! 13485 transition
    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...
    Matt Jensen
    Director, Regulatory Affairs
    January 2018
    Recommendations for professional associations and certifications
    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...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    January 2018
    Death by Risk-Based Approach, really just an internal audit?: Practical Guide
    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...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    January 2018
    How to Prepare for an FDA Pre-Submission
    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...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    December 2017
    Risk-based approach as clear as mud in the Practical Guide to ISO 13485
    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...
    Richard Bollinger
    Founder and CEO of Menlo Park Associates and Menlo Park Software
    November 2017
    FDA compliance crisis still a threat.
    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...
    Joe Hage
    🔥 Find me at MedicalDevicesGroup.net 🔥
    November 2017
    How to avoid the worst CAPA system implementation pitfalls
    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...
    « Previous 1 … 5 6 7 8 9 … 26 Next »

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