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2017

  1. bio_subbu

    EU Publishes New DIRECTIVE (EU) 2017/2102 AMENDING 2011/65/EU ON ROHS-2

    The European commission has published Directive (EU) 2017/2102 amending RoHS 2 Directive 2011/65/EU. This Directive shall enter into force on 11 December 2017, the following is a summary of the amendments affecting replacement of Spare Parts and Refurbished Electrical and Electronic Equipment...
  2. Sam Lazzara

    GS1 introduces Global Model Numbers for Medical Devices

    On 2017-09-07, GS1 introduced something new (I think) - Global Model Numbers (GMN). The detailed requirements are provided in the recently published GS1 General Specifications (Release 18, Ratified Jan 2018). Here is some information from Release 18: The GMN includes the GS1 Company Prefix...
  3. H

    From Christmas to New Year Celebration - 2017 - 2018

    I hope that you guys had a blast, so how did you celebrate the yuletide season this year?
  4. W

    "New" MDR implant card for absorbable substances

    Hi, A friend of mine asked me if I already read the new MDR (yes) and if I noticed chapter 18 ("Implant card and information to be supplied to the patient with an implanted device". As he works for a company which manufactures hemostats and adhesion prevention products (like oxidized...
  5. J

    Revised MDSAP Audit Model - Health Canada - October 30, 2017

    Health Canada sent a notice on October 30, 2017, stating: [I]Health Canada has received comments from Canadian medical device licence holders regarding the current audit-time model for MDSAP and subsequent annual surveillance audits. To address these comments, the MDSAP Consortium has...
  6. Marc

    Adventures in Design Quality Assurance - Two-week-old Pixel 2 XL displays

    Adventures in Design Quality Assurance - Two-week-old Pixel 2 XL displays are already showing burn-in. LG's terrible OLED panels have yet another issue. Ron Amadeo - 10/23/2017 Two-week-old Pixel 2 XL displays are already showing burn-in | Ars Technica
  7. Hershal

    College FOOTBALL 2017!

    This has already been a wild season. Last weekend FOUR ranked teams were defeated AT HOME by unranked teams! Not only rankings thrown into confusion, Conference rankings thrown into confusion! Thoughts?
  8. R

    R.I.P. Tom Petty 1950-2017

    Music legend Tom Petty dies
  9. Marc

    Food Processors and Blades - Weekend Discussion

    I ave a small food processor. I'm not even sure if it can be called a "food processor". It's about the same size as the "old" Salad Shooter's" were (I assume they still sell those...). It has been awhile, but having been diagnosed with Type 2 diabetes I am eating a lot more salads these days...
  10. D

    Looking for an Aerospace Consultant in the San Jose California Area

    Looking for an AS91XX consultant in the San Jose California region for a new small (8 - 10 people).
  11. BradM

    Hurricane Harvey - Texas - August 2017 - Any South Texas Friends out there?

    If you haven't ever heard it... Texas is big. Here in Arlington (400 miles North of Houston) we are actually having a fairly nice, sunny day. Not sure how much of this is making it outside of Texas, and to the international audience. But... this is big. Really big. Despite Houston being the...
  12. D

    IATF 16949 Cl. 4.3.2 - Customer Requirements vs. Customer Specific Requirements

    How can I differentiate between customer requirements and customer-specific requirements? I read the definitions in IATF 16949 but could use some help interpreting. :thanks: David
  13. Marc

    Solar Eclipse in the US on 21 August 2017

    For those of you in the US, where will you be during the Solar Eclipse in the US on 21 August 2017? Next US eclipse - April 2024. USA - 2017 August 21 Total Solar Eclipse - Interactive Google Map - Xavier Jubier .
  14. M

    IATF Tool for Leadership and Planning - 2017

    Been cruising this site for many years and have appreciated all the help that people have provided. Hopefully some of you will find this tool helpful for laying the foundations of your IATF16949 management system. .
  15. Y

    FDA PreCert Program for Software (Companies) - 2017

    This looks interesting: https://www.fda.gov/MedicalDevices/DigitalHealth/UCM567265 https://s3.amazonaws.com/public-inspection.federalregister.gov/2017-15891.pdf (this is currently in the 'unpublished' state - expected to be officially published tomorrow.) Curious if anyone might volunteer...
  16. Marc

    IAQG Cleveland, Ohio Meeting - October 16-19, 2017

    FYI - IAQG Cleveland Meeting - October 16-19, 2017 All information related to the IAQG Cleveland Meeting scheduled for October 16-19 2017 including hotel and registration is now online at the following link: http://www.sae.org/iaqg/meetings/calendar.htm I have already registered. If any...
  17. Sam Lazzara

    EU MDR Safety & Performance Requirements vs. MDD ERs (June 2017)

    I have begun my slow EU MDR digestion process by drafting a cross-reference between the MDR S&PRs versus the MDD ERs (Essential Requirements). You can access it here. If you are interested in a MS Word version, click here. I did my best to correlate the "old" Essential Requirements to the...
  18. A

    EASA Easy Access Rules for Continuing Airworthiness - June 2017

    EASA has jut released a set of consolidated regulations that might be helpful to visitors. It is a handy online resource that shows the current amended rules, and for each 145 regulation the Acceptable Methods of Compliance and Guidance material. There is also a good set of guidance material...
  19. somashekar

    UL Acquires Emergo - June 2017

    UL Acquires Emergo The acquisition positions UL as the premier service provider to the medical device industry by combining UL’s leadership in providing a range of services to support global regulatory approvals for the health sciences industry with Emergo’s global medical device registration...
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