2016

  1. S

    Summary of FDA Guidance on “Medical Device Accessories” (Dec 2016)

    Hi Fellows, Attached is the FDA Guidance on “Medical Device Accessories” from Dec, 2016. Below is a concise summary of the main points for your learning. Shimon =====================\\. 1. Definitions: Accessory: A finished device that is intended to support, supplement, and/or augment...
  2. Marc

    New FDA Cybersecurity Guidelines for Medical Devices (Dec 2016)

    New FDA Cybersecurity Guidelines for Medical Devices The U.S. Food and Drug Administration released its recommendations for how medical device manufacturers should maintain the security of internet-connected devices, even after they've entered hospitals, patient homes, or patient bodies. The...
  3. Q

    FDA To Publish Powdered Glove Ban Monday (December 19, 2016)

    You can download unpublished Federal Register here. They say "it was published on 12/19/2016" here.
  4. Marc

    The Passing of John Glenn - December 2016

    A Weekend Thought... I was going through some old threads and thinking back to when I first got into quality assurance in the 1980's. As I get older and so much of quality assurance these days seems so - Well, simple, I realize that the years have instilled in my "nature" so many of the...
  5. Marc

    AS/EN/JISQ 9100:2016 IAQG Sanctioned Aerospace Auditor Training Available (Nov 2016)

    The 9100:2016 Delta Training Program is now available for purchase in English, French, Italian, Japanese, Korean, Portuguese, and Spanish. German and Simplified Chinese are expected to be made available prior to December 9th. This program is mandatory for all current authenticated auditors...
  6. Marc

    Google Earth Timelapse update shows Earth from 1984-2016

    Google Earth Timelapse update shows Earth from 1984-2016. Timelapse is a global, zoomable video that lets you see how the Earth has changed over the past 32 years. It is made from 33 cloud-free annual mosaics, one for each year from 1984 to 2016, which are made interactively explorable by...
  7. Hershal

    COLLEGE FOOTBALL! 2016

    I had this as a series until couple years back. Anyway, now playoffs! Who should be in?
  8. Marc

    A special Supermoon comes—but what causes it? 14 November 2016

    A bit late, but a bunch of friends have been emailing me so I figured I'd pass it on. Supermoon - November 2016
  9. R

    Fare well, dear man - Leonard Cohen Dead at 82 - November 2016

    Leonard Cohen Dead at 82 http://www.rollingstone.com/music/news/leonard-cohen-dead-at-82-w449792 :(
  10. Marc

    Yahoo probes possible huge data breach - BBC News - 2016

    Yahoo probes possible huge data breach - BBC News I don't have an email account there, personally. Just a "Heads Up. NOTE from the article: However, attempts to contact more than 100 of the addresses in the sample saw many returned as undeliverable with auto-responses reading: "This account...
  11. Marc

    Employment in 2016

    Companies looking to recruit and acquire talent must now compete on a new battlefield - one shaped by new global talent networks and social media as well as defined by employment brands and changing views of careers. What are your thoughts?
  12. Marc

    Gene Wilder dead at 83 - August 2016

    I just watched a great interview with him about a week ago. Published on Jun 20, 2013 He was a very unusual person - One of my favourites. His on screen persona was quite different than his real life self. Gene_Wilder Gene Wilder, ‘Willy Wonka’ Star and Comedic Icon, Dies at 83 :(
  13. Hershal

    Fire disaster in Southern California (Blue Cut fire) - August 2016

    For those who may not be aware, So Cal has a real serious fire disaster. It is known as the Blue Cut fire. The smoke smell is really strong here at my place. The fire area is about half an hour drive from the house, so close. Here is situation as it is now. Started yesterday about 10:30 am...
  14. Marc

    Happy Birthday, Jim Wynne!

    Happy Birthday, Jim Wynne!
  15. P

    FDA has just released the forms for "Small Business Qualification and Certification"

    FDA has just released the forms for "Small Business Qualification and Certification" for the tax year commencing 30th September 2016. See here:-...
  16. M

    Elsmar.com Website goes down daily - August 2016

    I don't know if it is something with Elsmar or on my end but I thought I would report it. For about 1/2 my day, sometimes early morning, sometimes in the afternoon, when I visit Elsmar.com/Forums I get an error that says I cannot connect (like the site is down). I do not recall if this has...
  17. Hershal

    Star Trek Beyond (ST 13) - 2016

    I will wait for a few days to see this one till the crowds thin out a little. Also waiting on the ST:TOS Captain's uniform to come in from BABW for Camo (my bear). In the meantime, I have seen all the trailers. Now, they take off in a Constitution Class starship, but later seem to be in a...
  18. Marcelo Antunes

    MEDDEV 2.7/1 rev.4 published - June 2016

    Finally published, MEDDEV 2.7/1 rev.4 - Clinical evaluation: Guide for manufacturers and notified bodies (2016) - http://ec.europa.eu/growth/sectors/medical-devices/guidance/index_en.htm
  19. P

    Biocompatibility: Blue Book Memorandum #G95-1 superseded by new FDA guidance

    http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM348890.pdf
  20. Marcelo Antunes

    Updates on proposed EU Medical Device Regulations - June 2016

    Some recent developments on the proposal medical devices regulations in Europe. Announcement from last week: Medical devices: deal reached on new EU rules Official Journal 10-06-16 - Amendments on the proposal for revision of the directives - https://lnkd.in/eKTKRjC Revised Medical...
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