oem (original equipment manufacturer)

  1. DuncanGibbons

    Documentation aerospace OEMs require with purchase of parts from manufacturers/suppliers

    Hi all Can anyone help me with what documents aerospace OEMs (international OEMs such as Boeing, Airbus, Saffran, GE, etc) require with the purchase of parts from manufacturers/suppliers? Ideally for a titanium part produced from titanium powder. If anyone has specific codes for these...
  2. E

    Original Brand Labeler (OBL) in China

    Hi, Is an OBL accepted in China? Original Brand Labeler (OBL) is defined as a company which obtains equipment manufactured by other companies (OEMs) to resell that product under its own brand name – meaning, OBL Manufacturer will be the one placing the product on the market under their name or...
  3. A

    Certification procedure for OEM/PLM collaboration in the medical device industry in the US - Who bears the regulatory responsability?

    What is the certification procedure for OEM/PLM collaboration in the medical device industry in the US? Who must bear the regulatory responsability?
  4. P

    Sterilization Subcontractor of OEM

    As OBL we are starting a collaboration with OEM whose one of subcontractor is the sterilization facility ( company has the EN ISO 11137 certification (gamma sterilization)). Unfortunatelly, NB requires tripartite agreement. OEM is a customer of the sterilization facility and they are...
  5. B

    IATF 16949 7.1.5.3.2 FAQ #7 Audit Finding - External Calibration Laboratory

    Hello! Long time lurker to this forum, decided it was finally time to get my feet wet by sharing a recent experience. IATF FAQ #7 for External Laboratory states: QUESTION 1: When can the equipment manufacturer be used to calibrate inspection and test equipment? If an accredited laboratory...
  6. S

    Beginner trying to OEM a medical device - Branded Electric Acupuncture Pen

    Hi, I run a handful of online stores and have recently been exploring importing a branded Electric acupuncture pen into Germany. However usually I sell clothing and I have been shocked at the amount of regulations it looks like I will have to comply with. There is a very relevant thread...
  7. H

    Can an OEM use an CM ISO 13485 certification in helping to get out CE Mark?

    As an OEM can we use an CM ISO 13485 certification? Can an OEM use an CM ISO 13485 certification in helping to get out CE Mark?
  8. Ajit Basrur

    Looking for a Design Transfer Checklist

    I am looking for a Design Transfer Checklist especially for an OEM to transfer the design to a Contract Manufacturer. Thanks for your help!
  9. J

    Virtual Manufacturer and CE Marking

    Hi, Does an OEM need a CE mark on their product in order for a virtual manufacturer to gain one? For clarity - the OEM has a FDA 510k on it, but the OEM has no intentions of selling in Europe themselves. However, the virtual manufacturer wishes to do so. Is it necessary for the OEM to gain a...
  10. S

    Is Certificate of Conformance required for an OEM released product?

    Back in contract manufacturing, the manufacturer issues a certificate of conformance (CoC) or certificate of analysis (CoA) based on the contracted agreement. But for an OEM, who gets the prodyct manufactured at a contract manis it common for OEMs to prepare the CoC or CoAs?
  11. N

    Regulatory Responsibilities of an OEM and Private Label manufacturer

    Hello, What are the regulatory responsibilities of an OEM and a Private Label manufacturer? We are a small manufacturer of components (not finished devices) and are looking into the prospect of manufacturing finished medical devices for a private labeller in Canada and US. We are...
  12. S

    OEM and PLM under MDR

    Hi again, not sure what's the best way for conformity assessment in case of OEM and PLM: Company A: designs and produces many medical devices Company B: asks company A to make small changes to some of the products and label it under company B name (it is identified as the manufacturer)...
  13. supadrai

    Indonesian MOH Regulation Restricting OEM/Private Label Medical Devices

    Hello All, As we're just going through this, I'll share what I know. By way of background, we are a Thailand-based Medical Gloves manufacturer that distributes on an own-brand, private label/OEM basis, globally. Effective 12 January 2018, an Indonesian Ministry of Health regulation...
  14. C

    How long is an OEM obligated to provide spare parts and repair

    My company was an OEM of a medical device for a distributor. Our agreement has since ended. We haven't removed the product from our listings, we just don't manufacture it anymore. How long must we provide repair or spare parts for the device to that distributor? I'm assuming there's a ruling of...
  15. S

    Virtual manufacturers/OEM - CE/ISO requirements

    Hi all, we(as a virtual manufacturer) want to add few OEM products in our product list and sell those products in our name and also put CE marking. The OEM already have CE. Can we put "manufactured by" our address and use their CE marking. or shall we get the technical file from...
  16. C

    Relabeling Product Manufactured by the OEM

    Hello, I have a question that I’m hoping someone here can help me with. Our company wants to put a label onto a product made for us by the OEM. The product falls under Class II for the FDA and IIa within Europe. The OEM is the 510k holder and sells this product globally. Can our company apply...
  17. M

    Piggy Backing on OEM's CE certificate

    Hi guys, We've been waiting for a really long time to get our new products CE marked. But we have huge demands from our customers for the product and unable to sell due to the product not listed on the CE cert. Is there a way we can piggy back on our OEM's CE certificate and sell the...
  18. B

    Virtual Manufacturer / OBL ISO Requirements

    Hello, my company is an Own Brand Label (OBL) medical device manufacturer and are in the process of implementing a QMS and planning to market within the EU. I would like to know if anyone has any advice/guidance on how to manage our sourced Original Equipment Manufacturers (OEM) per the new...
  19. M

    OEM-OBL ISO 13485 Certification - Devices mentioned in the product scope

    Hey guys, This seems like a dumb question but just to be very sure: The OEM manufacturer of the devices mentioned in the product scope of the OBL's ISO 13485 & EC cert, must have a valid ISO 13485 & EC cert of their own. If their certs do not cover those devices, then the NB of the OBL will...
  20. D

    Hot Plate Welded Plastic Strength Validation

    Does anyone have any experience with hot plate welding? I have a new part that is made by hot plate welding 2 pieces of plastic on the edges and interior ribs. I am attempting to validate the strength of the weld and am having a hard time finding any baseline specifications for a DT. I am...
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