1. QIE

    FDA 21 CFR Part 11 "Meaning of Signature"

    We're in the process of moving from paper based document control to electronic. In looking at Part 11 compliance, Subpart B, Section 11.50 (a) states: Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: (1) The printed...
  2. U

    Hand-Held dosing device has no PATIENT - Interpretation of the PATIENT definition

    Hi everyone, For the past year I've been working in a team developing a HAND-HELD dosing device for people that today administer their prescription drugs with pills or capsules. The idea is to load the device with pellets and then dispense pellets on the demand of the "patient". The reason for...
  3. C

    MDR Importer/Distributor Definition Questions

    I have a question that I am hoping someone may be able to answer. The first is the definition an "importer" as used in the MDR. It states: "importer" means any natural or legal person established within the Union that places a device from a third country on the Union Market: " My question is...
  4. W

    Documentation - Use of Addendum vs Amendment

    Hi all, Our procedure has the following definitions: Addendum: additional pages or sections that are added to an existing document Amendment: minor changes to pages of an existing document, correcting an error in the original document, or supplying supplementary information to clarify the...
  5. G

    Differences - Nonconformances vs CAPA, Corrections vs Corrective Actions

    I'd appreciate people's thoughts on the following regarding how/what system our medical device company uses for NMRs, CAPAs, corrections, corrective/preventive actions... As the head of Quality for my company, I hold regular meetings with influential members of my organization to discuss...
  6. G

    Medical Device "Immediate Container" Interpretation of Definition

    Does the injection molded housing of an over-the-counter device in retail package form constitute the "immediate container" and thereby all markings required to go on the "label" of a device (name and place of business of the manufacturer, packer, or distributor, UDI) must be displayed "upon" it...
  7. 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...
  8. 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...
  9. 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...
  10. 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...
  11. I

    What does "Class" mean in an FMEA?

    what does "Class" mean in FMEA?
  12. 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...
  13. 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...
  14. 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...
  15. 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...
  16. 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...
  17. 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...
  18. 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?
  19. 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...
  20. 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...
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