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21 cfr part 820 - med. device mfger. qsr requirements

  1. E

    MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP

    Hi there! We're a small Canadian company that manufactures medical devices for the Canadian and US markets and have a MDSAP audit scheduled for later this year. From what I've gathered online, the MDSAP program framework mainly consists of ISO 13485:2016 and GMP, in our case FDA 21 CFR Part...
  2. D

    FDA QSR task checklist based on inspection citations

    Will a Quality Management System (FDA QSR) task checklist derived from the last 10 years of FDA inspection citation data be a handy tool for all you QMS builders in the medical device industry? How helpful will it be to you? I am planning to make an interactive checklist as part of my project...
  3. Q

    How to efficiently and compliantly reference external standards/regulations

    I am looking for advice on how to efficiently and compliantly reference external standards/regulations. I work for a small medical device company and we are rapidly expanding into new markets and with that we are now governed by over 100 standards/regulations. Historically we would cite 21CFR...
  4. rmf180

    21 CFR Part 820 Contract Manufacturer of Medical Device Component

    I work for a medical device component supplier who is now being asked to register as a contract manufacturer for a specific device. As we have been supplying components for many years, we comply with most of 21 CFR 820. The primary exception is design. In this case, we still will not be...
  5. E

    Sample size for design verification of variable in single use device

    Hi All, long time reader, first time poster. I am a mech. engineer, frequently involved in "bench testing"of medical devices. I have trauled through the forums many times over the last few years on sample size selection and never really get much wiser. I've asked as many colleagues as I can in...
  6. B

    Classes/ Online Training on ISO 13485:2016 and FDA QSR Part 820

    I am taking over the QA/RA Management Representative role for my company and looking for some classes and/or online training for FDA and ISO 13485. We have a couple Class 2 medical devices(Dental Imaging Software & IntraOral X-Ray Sensors) and two Class 1 medical devices (IntraOral Camera &...
  7. T

    RISK: Selling Diagnostic Devices on Amazon

    HELP/ADVICE PLEASE I have once again been asked by our CEO about selling our trademarked Class I and Class II biologic culture/diagnostic devices on Amazon. Our marketing director is convinced that we need to be in this arena... The idea of using Amazon makes me VERY nervous as some of our...
  8. D

    Design developer - 21 CFR 807 - do we need to register?

    Hi all, we (party A) are an EU engineering service provider. We are ISO 13485 certified but not (yet) QSR 21 CFR 820 compliant. Our US customer (Party B) wants to approach US market first. We develop (design) a medical class II b device for them, but do not manufacture the device. Manufacturing...
  9. 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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    Defining Approvals Required for Design Control Documents

    Associates, I'm generating templates for design controls per ISO 13485:2016 and FDA 820.30, but am struggling to find any guidance on approvals necessary for different document types. I know there's some flexibility in who the organization identifies as required signatories on documents per...
  11. T

    Effective Date on Documents

    All, Please correct me if I'm wrong - within 21 CFR 820, ISO 13485:2016, and the MDD, I cannot find that having the effective date on a document is required. All that is required is that the document was reviewed and approved, has an identifier (e.g. name, number, revision level, etc.)...
  12. J

    21CFR820 requirements for Foreign Exporter?

    Could anyone advise if a Foreign Exporter only needs to have their establishment registered with the FDA, or would they need to ensure they have processes in place to follow FDA regulations for medical devices (21CFR820 specifically) as well?
  13. S

    What is the significance of UDI date requirements for Class 1 devices?

    FDA issued a guidance establishing enforcement discretion that applies to FDA established compliance dates for certain class I and unclassified devices as set out below: Class 1 and unclassified devices manufactured and labeled on or after September 24, 2018 FDA does not intend to enforce...
  14. J

    Supplier controls for consumer-grade off-the-shelf products

    Hello - I'm currently working on supplier evaluation and qualification for a medical device software company. All supplied products are off-the-shelf and/or available to the general public, such as cloud and web services, PC hardware, etc. Am I required to monitor such suppliers (e.g. Dell...
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    ISO 13485 certified as precursor to regulatory compliance to 21 CRF Part 820?

    Hi sorry if this has question has already been asked, but I can't seem to find an answer. Is it necessary to be certified to 13485 before ensuring conformity to 21 CFR Part 820, for sale of medical software in the USA. We are a small biotech spinout, and the plan is to obtain FDA...
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    Lot or Batch definition for IVDs

    US Regulation (21 CFR Part 820 (m)) Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that is manufactured under essentially the same conditions and that are intended to have uniform characteristics...
  17. L

    21CRF820.70(g)(2) Maintenance Inspection Interval

    Hi, 21CRF820.70(g)(2) states “Inspection. Each manufacturer shall conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules. The inspections, including the date and individual(s) conducting the inspections, shall...
  18. N

    Change Control - Compliance with FDA 21 CFR Part 820

    Hello Everybody, I have been working in QA for 7 months now and have been tasked with updating our change control procedure. We are ISO13485 certified and also need to comply with FDA 21 CFR Part 820. We don't currently have enough controls in place with change - we are able to amend...
  19. D

    21 CFR Part 820 (Subpart A) - Question about "Authority"

    Good evening, Near the start of CFR 820, in Subpart A, 820.1 Scope, (c) Authority... , it says, "Part 820 is established and issued under authority of sections 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803 of the act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h...
  20. K

    510K statement Questions 21 CFR 807.93 - Discontinued or never released for sale

    Hello, I am hoping someone can lead me in the right direction, or some direction would be helpful. I am trying to find guidance on 21 CFR 807.93, this is the premarket notification statement that says you will provide copies of your 510k to anyone who asks within 30 days. 1. If the...
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