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  • Software Requirements

    Firstly, how would the pack apply to Software as a Medical Device (SaMD)? Looking at the preview there is a lot that seems unnecessary as it is focused on the development of a physical product?

    Secondly, on the software front where would Software Requirements be specified (e.g SRS Doc) is this kept as an external doc and referenced? On a similar line, what about Software Testing (e.g. unit testing, user testing)? Would you again keep an external record and link to it in the “Record of Software Validation”?

  • Section about intended use

    IN the toolkit we have purchased, I cant seam to find a section about intended use. Which document caters for that? What ive found so far is just technical file, but not to the extent I thought was required.

  • Design and development process

    I want to ask about clause 7.3 of ISO 13485:2016. If we produce a medical device that is equivalent to another device in the market but make some changes to it, is clause 7.3 applicable for us?

  • Resolution timeline for closing NC's and MDR/UDI and EUDAMED

    1. Hello, Could you advise on defining the resolution timeline for closing Critical, Major and Minor NC ? The product is '' image viewer software ''?

    2. Could you advise if the company preparing for MDR transition from MDD needs to register for UDI/ EUDAMED if they will not be placing the product on the EU market?

  • ISO 13485:2016 , regulatory requirements

    I would be interested in the process of meeting the regulatory requirements according to ISO 13485:2016. What are the mandatory documents ? How to handle the review process for all standards/ legislation and other regulatory documents in the company ?

  • Requirements for SAMD

    I am looking for some help on Health Canada requirements for SAMD ( software as Medical Device) for a Dental radiology software. I feel it is classified as class II.

    Please let me know if you have any knowledge on this- which clauses of ISO 13485 can be excluded>

  • Multiple titles

    Under ISO 13485, would the FDA have a problem if the CEO of a company would also have a business card that shows him or her as a business development representative? Two business cards with two separate titles?

  • Applicable exclusion from standard

    We manufacture IVD Rapid Test Kits (Malaria pf, Pregnancy etc.). As you can see on the attached, our medical device manufacturing processes involved Purchasing (Raw Materials), Cutting, Assembling, Sealing, Packaging & Labeling and Marketing & Sales. We do not service our devices and there is no software validation. What exclusion from the standard is applicable in our situation? Hope to hear from you soon


  • Quality manual & Procedure under the ISO 13485:2016

    I am newly join to a medical device supply company which under the restructuring the management and nature of its businesses. The company has certified to the ISO13485:2016. However, under the new structure of business strategy, few activities of the company (as such production of medical device) is taken off from main process line as few others as well.

    My question is, do the company need to revise the entire documentation of Quality manual/procedure before the upcoming survelience audit?

    Will it impact the certification to the ISO 13485:2016

    Please help to highlight your opinion on my curretn situation to corelated it with the certification of ISO 13485:2016

  • Admin verification checks and physical verification checks

    Is there any forms available for admin verification checks and physical verification checks?

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