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ISO 13485 & EU MDR - Expert Advice Community



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  • Validation of equipment

    Hi, I was wondering if it is a requirement according to ISO 13485:2016 to use validated equipment during manufacturing and QC of IVDs

  • Distributors role in UK MDR changes


    Would anyone have any upto date information documents on the role of distributors in UK MDD/ MDR.  With the changes of the MHRA now extending the deadline also, some of my customers and sub distributors are asking me questions that I don't have answers to, becasue as far as I was aware I can't see any changes that imapct distributors.



  • Questions on Training Procedure and Procedure for Infrastructure and Work Environment

    1. The reason of my mail is to ask you on which document of the toolkit can I find the one that describes the trainings product?

    2. On the Procedure for Infrastructure and Work Enviroment document, on section 3.5 (Monitoring and measuring environmental conditios) I wonder if this section is necessary environmental conditions nor a cleanroom to do the device, the device is not invasive and it's mostly a software with sensors to check basic vital signs using IoT. Thank you very much for your help and I'll be
    waiting for your answers.

  • Human resources appendixes question

    This week we're working on the Human Resources documents and a few questions came up:

    1. On the company there are a few courses from Udemy and Coursera that some employees have taken and others that are currently taking them, ¿are these courses considered as training programs so I can put them on the 4.1 and 4.3 Appendix?

    2. Are training records (4.2 appendix) fully necesary? It's just that we currently don't implement trainings to monitor performance and we don't have trainings to fill the document, also, I understand this appendix refers to trainings that are needed due to bad performance, ¿am I right? Let me know if it refers to something else. 

    Thank you very much and I'll be waiting for your answer.

  • Difference in UK and USA ISO 13485

    I need to know if there is a difference in UK and USA ISO 13485?

  • Human Resources Training

    The reason of my message is to ask you something about the Human Resources Procedure and Trainings. The thing is that we develop a product and then we give trainings to doctors so they can use it. So my question is: ¿where should we include this training information? Because doctors are not employees of the company, they are users of the product, my question came in while filling the Procedure for Human Resources appendx.

  • 21CFR-820 vs ISO13485 Quality management systems

    Hello, we purchased the ISO13485 kit from you guys and I have a question.. We have a QMS for our NIOSH/21CFR-820 doing some research the QMS requirements are very similar, the ISO13485 is more company operations and the NIOSH/21CFR-820 is both operations and product. Since we already have the NIOSH/21CFR-820 can we use this QMS for ISO13485?

  • Sterilization need

    I have a question concerning sterilisation and whether it is required in our specific medical device area that we aim to work in. We will be making topical application products such as cream, gels or balms for eczema, acne, scalp issues, etc. The product itself won’t be sterile, but I was wondering if there was any other sterilisation process to be implemented, like equipment, packaging, etc.

  • Certification Requirements

    Are there any specific requirements for which certification bodies we use for ISO 13485? In IATF it mentions the certification body needs to be accredited by an IAF MLA member.

  • Should we have risk management procedure including FMEA for all product lifecycle?

    We bought the toolkit MDR/ISO13485 and have the following question:

    If we are a manufacturer (specification holder) and we have contract manufacturer for all our products (so practically we outsource design and development and all manufacturing stages but we only do sales activities for products under our brand name/trademark), should we have a risk management procedure including an FMEA for all the product lifecycle? Or we only make a quality agreement with the manufacturer (OEM) which includes all the requirements and we supervise implementation?

    A note all our contract manufacturers are MDR Compliant and ISO 13485 Certified.

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