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  1. Marc

    RFS - Regardless of Feature Size (GD&T)

    REGARDLESS OF FEATURE SIZE (RFS) Regardless of Feature Size (RFS): RFS is the default modifier. so if there is no modifier symbol shown in feature control frame, it means RFS is the default modifier. RFS is used when the size feature does not affect the specified tolerance. Source: GD&T...
  2. A

    Definition of "Sensitive Products" Clause 8.5.4 (c) in AS9100 Rev. D

    We were recently given a minor nonconformance from a customer against clause 8.5.4(c). The auditor interprets the "special handling and storage of sensitive products" as chemicals (such as epoxy or adhesive). In my 13 years of AS9100 auditing, it has always been audited as product, such as ESD...
  3. F

    Reprocessing or refurbishing? Single Use Medical Device

    Hello all, I'm working as a not so experienced QA/RA Manager for a startup that is developing a class IIa medical device. Our product is intended as a single use and is composed of an electronic board powered by a single use battery, a casing and an adhesive to stick it on the skin of the...
  4. T

    MDR article 22 - System of 2 CE products and validation / usability?

    Hi, I am discussing this with our RA and PO team and would appreciate more input on this matter.... Article 22 of the EU-MDR describes systems as "‘system’ means a combination of products, either packaged together or not, which are intended to be inter connected or combined to achieve a...
  5. I

    What does "Class" mean in an FMEA?

    what does "Class" mean in FMEA?
  6. Marc

    Jidoka - Definition

    Jidoka Autonomation - Wikipedia Autonomation describes a feature of machine design to effect the principle of jidoka (自働化) used in the Toyota Production System (TPS) and Lean manufacturing. It may be described as "intelligent automation" or "automation with a human touch".[1] This type of...
  7. Marc

    DFMEA (Design FMEA) - Definition

    From Experience in: Airbag Restraint Systems Anti-Lock Brake Systems DoD Aerospace High Reliability Electronics In your Design FMEA you are doing a risk analysis of the product function. In short - If the product fails, what is the potential risk? If you really are into it, there was a series...
  8. Ed Panek

    Sterilization vs Disinfection - Wearable bandages that report a health metric via Bluetooth

    We sell wearable bandages that report a health metric via Bluetooth. Our CE auditor said we have to sterilize the bandages before we get the back to troubleshoot broken ones. I think he meant disinfected and not sterilized. For me sterile means entering the human body. To review the bandages...
  9. I

    "Method" vs "Process" - Differences

    I've been considering addressing some of my processes with the concept of "method" as opposed to "process" - I've been advised that a method does not need to be in a document - BUT - the burden of proof for a method is more difficult for an internal audit team to verify as EACH member of the...
  10. J

    Definition of repackager v. manufacturer

    Hi all, We are having an internal discussion regarding the registration with the FDA of a potential medical device. We are looking at ways to source this device and the different methods of sourcing impact how we register with the FDA and label the product. In this case, we have the option to...
  11. Marcelo Antunes

    Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia

    TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Continue reading...
  12. T

    Series A ready company - Term for medical devices companies?

    Is anybody familiar with "series A ready company" term for medical devices companies? Who prescribes criteria for becoming such a company and which criteria are to fulfill?
  13. K

    IoT, AI, Big Data and National Strategies of Other Countries (in your country, do you have any?)

    Hi. I attended a seminar today here in Singapore. The title: "CS Seminar: An Overview of AI in Data Mining, and Graph Embedding sponsored by a Singapore-based organization that develops advanced AI technologies to gather, analyze and predict digital signals from unstructured and structured data...
  14. S

    How are Medical Device Components and Subassemblies defined?

    Hello everyone, As a medical device manufacturer, how are components and subassemblies defined? I associate components with the parts that come in from the suppliers, for which there is inspection/testing done upon receiving. A subassembly consists of components put together, and final...
  15. S

    DO 178B - What is the difference between review and verification?

    Hello All, In DO178B process, we will prepare requirement review checklist as per "Table 3 Verification of outputs of software requirement process" but table heading is verification of output. Then what is the difference between review and verification?Usually we will verify the requirements...
  16. MichaelDRoach

    ISO 9001:2015 Clause 9.3.2c)3) - What process or processes is this focused on?

    I'm looking to find just what does it mean in 9.3.2c)3) "Process performance and conformity of products and services"? What process or processes is this focused on? I can understand the conformity of products and services.
  17. A

    Where are the rules for when a repeat minor nonconformance becomes a major?

    Can someone answer a question I have had for some time? If a CB auditor issues a "minor" non-conformity and a year later at a subsequent visit discovers a similar "minor", (same clause or part of the QMS) the "minor" automatically becomes a "major"? I have reviewed the Rules and I can only find...
  18. S

    MDR Annex II Design & Manufacturing info - 'Adjuvants' definition

    Hi, Please could someone help me to understand what is meant by the phrasing of the word 'adjuvants' used in MDR - Annex II - Design and Manufacturing Information. (b) complete information and specifications, including the manufacturing processes and their validation, their adjuvants, the...
  19. sonflowerinwales

    Anodyze - what is it?

    Good evening all In our requirement to our supplier it states - The following materials shall be avoided: - 1. Anodyze - 2. Fiberglass material - 3. Paint (white) (others listed also...) Then at the end fo the paragraph - Note: The reason is that they have a known association with ESD risks. I...
  20. M

    IEC 62304 - Develop an Architecture for the Interfaces of Software Items

    What does IEC 62304 cl 5.3.2 - Develop an ARCHITECTURE for the interfaces of SOFTWARE ITEMS refers to? What does ARCHITECTURE of the interfaces means? Is it expecting descriptions of the methods instead of defining the actual interfaces? For examples, there are two MCUs and one SOFTWARE ITEM...
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