1. K

    Design and Development Exemption/NA confusion

    hi All, sorry if this is not in the right place and that I explain it adequately! I've recently started work for a manufacturer of IIa devices in QA/RA and I am trying to update the QMS to address the newer revision of 13485 and the MDR. we also distribute items for another company...
  2. M

    ISO13485:2016 - Exemption vs. Not Applicable

    Good morning, Our CB auditor said something during his last audit about separating out the exempted requirements from those that are not applicable. Trying to differentiate without having access to a definitions standard am I correct to say that "exemptions" are for when a whole section...
  3. M

    "Partial Design" Designation and Applicable ISO 9001:2015 Exemptions

    My company is an EMS provider for a variety of customers. As a result, we do not do PCB design or participate in the design process for the most part; however, we provide do DFM analyses when we run into a problem or in order to provide cost savings, etc. We also provide a workspace for our...
  4. G

    ISO 9001:2015 8.3 Design and development of products and services

    We have always looked at requirements for Design and development (9001:2008) as an exempt clause, stating that as a business we don't covert a customers (external end users) specification(s) into a product, we supply a fixed product. However, I'm always cautious of the view that we may design...
  5. B

    RoHS Directive 2014/5/EU Leaded Solder Exemption

    This exemption directive is included as one of Directives 2014/1/EU - 2014/8/EU that were published on October 18th of 2013. It regards a leaded solder exemption for components, connections, cables and assemblies that are designed to operate at below -20 degrees C. The other 7 directives all...
  6. Q

    Is Medical Device 510(k) exempt or not really exempt?

    Hello, Can someone help me understand or give me some insight on this scenario? Current Machine is an FDA Class II and has an FDA Product Code with a regulation number that states that such machine is exempt from premarket notification regulations. We make design changes/modifications to the...
  7. Q

    Mexico Medical Device Registration - Private Hospital Exemption

    Good Morning everyone, I have a US distributor who takes delivery of medical devices in the US but who we recently found out intends to sell these products into Mexico. We have questioned him about his registration process and whether or not he has performed such registrations (since we've...
  8. A

    Confirming IVD exemption from WEEE

    Hello Cove Users, I have a question in relation to confirming IVD exemption to WEEE. The product I am trying to confirm exemption from WEEE is an instrument which is used in conjunction with IVD consumables for testing human serum/plasma samples. The product is general class according to...
  9. A

    CFDA - List of Class II Medical Devices exempt from Clinical Trials

    Does anyone have access to this list? I couldn't find it in the CFDA database. Thanks, Aaria
  10. J

    RoHS Components with Lead Exemptions (Capacitors on a PCB)

    Probably a dumb question but... If my companies products are to be 100% RoHS compliant with no exemptions, do I have to make sure I do not buy components that say they are RoHS compliant but have a lead exemption? For instance: Our product claims lead-free but one of the capacitors on a PCB...
  11. Q

    Search for FDA Class I Medical Device Listings

    Hello, does the FDA website offers a possibility to search in the list of apporved Class I 510k exempt medical devices? There is a search form for all kind of cleared 510ks, but not for exempts.
  12. sideoiler

    Specification Verification Responsibility

    I have been having some recent issues with a certain customer who for the 3rd time now is rejecting parts based off of superseded specs. I am curious as to who's responsible for making sure the specs called out on Prints / Build Sheets are current and not superseded. Both the customer and the...
  13. V

    Webasto Ford Exceptions Form

    Are any of you aware of an exceptions form, like a GM-1411 that is specific to Webasto or Ford? I searched Covisint with no luck.
  14. C

    Could I be exempted from the CoC requirement?

    We are a contractor for a major aerospace co-. Our customer has no requirement for a DPD/MBD approval as strange as that sounds. But we do,and we did not qualified our supply base for the DPD/MBD standard for whatever reason. We are constantly sending digital data set to the suppliers and...
  15. Q

    FDA and Medical Device Exemptions from GMP Requirements

    Hello Fellow Quality Gurus, First, please don't shoot me if I didn't read all of the threads that exists about this topic. If I missed it, I'm sorry. Just asking for help and direction. I want to make sure that I understand this correctly of the following statement. One of our devices is...
  16. T

    CFDA issued second list of Class II devices exempt from clinical studies (10/11/13)

    CFDA issued the second list of Class II devices that are exempt from the requirement of clinical test data for product registration. Manufacturer may send a written request for such exemption. The list is effective on the day of issuance and does not apply to any registration submission sent...
  17. N

    Can a specific division of an ISO 9001 company be exempted?

    Hello, My company is ISO 9001 registered for the manufacture of a specific product, but also has a division that produces an entirely different product under a different name, though it's technically the same company. Is this second division then required to use the quality program too? ISO...
  18. K

    Product Realization in 'Training' - 7.3 Design And Development Exemptions

    Hi, I am new to ISO 9001 but am working towards getting the small Registered Training Company that I work for certified. I am very confused as to what our product is. Is it the training itself? And because we modify our training manuals from the training package. Does that mean that we would...
  19. J

    FDA Routine Inspection Pre-Anouncement - What will be checked?

    We are a european manufacturer of a medical device, class I for FDA, class I for europe. Exemt from premarket approval, not exemt from GMP. We received the pre-announcement for a 4 day routine inspection. We have only 12 employees. How much of the 21CFR820 will be audited? Am i correct...
  20. R

    510(k) Exemption: Powered Patient Transport / Wheelchair Elevator (Stairlifts)

    http://www.gpo.gov/fdsys/pkg/FR-2012-06-01/html/2012-13225.htm?source=govdelivery http://www.gpo.gov/fdsys/pkg/FR-2012-06-01/html/2012-13224.htm?source=govdelivery