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  • Design & Development consultation

    I am *** from medical device (glove manufacturer) company. As the pic for the design & development , would like to get more understanding regarding design & development as per 1S0 13485 (also MDSAP if can). There are few question from me which hope you can advise:

    1) We are OEM company, so one product will be sell to few customers.
    a) the market region might be differ according to customers. So how should I put into the design input as it also covers the markets region. Example, the product is design to customer A for US market. After few years customer B would like to purchase the same product but for Australia market. Should we just revised the design input or need to remark into design changes? Need your comment.

    2. Can you elaborate further for IS0 13485 clause 7.3.3 Design Inputs which stated " Requirement shall be complete, unambigous, able to be verified or validated, and not conflict to each other" ? How can we verify these ?

    Looking forward to your reply. Thanks.

  • Maintaining ISO 13485 certification

    The company has just been certified with the 13485. HOW do i maintain this certification and what are the documents I need for the day to day maintenance
    Our certification requires an annual audit can i just start a few months prior or this a constant full time day to day effort.

  • QMS

    I have a question regarding QMS and I am just wondering if you could help me with advice.
    I am working for a software company which develops stand-alone SaMD and trying to establish a QMS (ISO 13485) but the clause 7.6 makes me confused. We are only using software tools (automated software development tools, source code management tools etc.) without any measuring and monitoring functions, no calibration needed, therefore, those "equipment" according to my interpretation does fall under 6.3 infrastructure (b) process equipment software. I would control (maintain) them as part of 7.5.6 Validation and documentation of computer software SOP and the records of these activities would be maintained accordingly. 
    Is it possible to exclude 7.6 if I can ensure the validation of software under the umbrella of 4.1.6, and 7.5.6?

  • 58 areas of compliance required by ISO 13485

    In order for an organisation to be able to demonstrate compliance within the requirements of ISO 13485 and maintain approval from a certifying body ( 3rd party audit ) there are 58 areas that company must demonstrate adherence to. This need was highlighted from a white paper you sent me. Would you be able to send me details of the 58 areas of compliance required by ISO13485:2016?

  • Availability of parts and components for a discontinued medical device

    On discontinuation of a medical device, it is compulsory for the manufacturer to continue to provide parts and components for the discontinued device. The period that the manufacturer must continue to provide the parts and components is equal to the lifetime of the device. The devices sold last need to be covered for their lifetime regardless the discontinuation. The (expected) lifetime of the device is defined in the technical documentation.
    1. Correct me if I am wrong/not complete.
    2. Is there in any other part of MDR (except for GSPR .6? combined with the definition in the device’s technical documentation) where this obligation is laid down?
    Thanks in advance for your advice

  • EU IVDR 2017/746

    I understood from the webinar that implementing ISO 13485 is a direct way to comply with most requirements in EU MDR 2017/745.

    Can the same be stated for EU IVDR 2017/746? Ie that it is beneficial to implement ISO 13485 to comply with IVDR?

  • Signing electronic documents

    We are preparing for an inspection, which will be next week on Thursday. (FDA Mock). Which point of the regulation states that electronic documents do not need to be signed? Is it allowed to use the Google Suit system at a medical device manufacturer? (Data stored in the cloud. If not which rule can I refer to.

  • Implementing ISO 9001 alongside ISO 13485

    We are designing a system to transport medicine by drone. We understand we need to have ISO 13485 certification. Do we also need to have an ISO 9001 certification or is 13485 a superset of 9001? Thanks.

  • How to use the ISO 13485:2016 Internal Audit Toolkit

    I am looking for templates to use for conducting internal ISO 13485:2016 audits, such as Audit plan or Working documents (checklists, agenda, report). These templates appear to be designed for an audit of an entire company, how could I use them to audit one department at a time?

  • Medical devices vs. AI and software driven medical devices

    if I have to establish and develop ISO 13485 for a company predominantly is AI and software driven medical devices, what are the main differences between medical device vs the above mentioned medical device.
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