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  • 15223-1 and 13485 certification question

    Do i need to purchase iso 15223-1 in order to comply with a medical device app? Furthermore can the iso 13485 certification and the CE certification be done by the same organization?

  • Lot number coding

    Our company recently purchased Advisera’s package of ISO 13485 templates for implementation in our company as we are starting producing class I medical devices (surgical gowns) to supply the Portuguese market as soon as possible.

    I’m aware you provide a meeting to discuss doubts about the templates provided, but at the moment I’m in a hurry to solve an issue regarding the lot number coding and I didn’t find any information about that in the package purchased.

    Is there any template to help us code the lot/batch number of a medical device or mandatory information that we should include in that code? We want to allocate that code automatically, but we don’t know what requirements to demand from the automatic batch number allocation.

    Would you kindly help me with this matter?

  • ISO 13485 implementation duration

    Small contract engineering firm, 10 employees. Decades of experience in product development but little in med devices. Starting from nothing, about how long should it take to achieve 13485 certification using the right consulting firm to assist?

  • Can contract manufacturer exclude validation from their scope?

    I just want to know if it is possible that a contract manufacturer can exclude validation from their scope?

  • Preparing site for first-time ISO 13485 audit

    How to prepare the site for the first-time audit for on 1ISO 13485?

  • Guidelines for complying with ISO 13485 regarding validation and computerized system validation

    What guideline do you recommend to use to comply with ISO 13485 regarding validation and computerized system validation. We will not need to comply with FDA guidelines. Please share any recommendation.

  • Calibrating instruments after due date by fixing the window period

    I have one doubt, can I calibrate the instruments after the due date like by fixing the window period. Is it acceptable?
    Example: Calibration due date is 10 September. the window is 5th to 15th September, can I calibrated 12th September after the due date.

  • ISO 13485 workflow explanation

    I want to get detailed explanation of workflow of ISO-13485 which i have .I am not able to explain it to my manager how this ISO works from beginning to end step-wise like starting from section 4 to section 8.

  • ISO 13485 Lead Auditor

    1. Is it possible for An ISO9001:2015 auditor to audit Medical Devie manufacturer?
    2. How can I qualify myself on ISO13483

  • Differences between EU MDR and US FDA regulations

    What are the differences between EU MDR and US FDA regulations?
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