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  • Is clean room installation mandatory?

    Hi there, the questions is - Does ISO 13485 depict that there has to be a clean room installed?

  • Information on risk classification for IVDs under new IVDR regulations

    I need more detailed information on risk classification for IVDs under the new IVDR regulations. This is referring to the EU IVDR.

  • Requirements for custom service business to be compliant for ISO 13485

    what are the requirements for custom service business to be compliant for ISO 13485?

  • Parameters for clean room

    I am looking for parameters for clean room

  • Some Information regarding ISO 13485 and ISO 9001

    I am working in a manufacturing company of surgical masks in Dubai I want to know does Manufacturing of Surgical Masks lie under the ISO 13485 scope? and If We implement ISO 9001 in our company, does we require to implement ISO 13485 in the company or is it same..

  • Is ISO 13485 for medical devices only?

    ISO 13485 is for medical devices only or for products as well like hand sanitizers and chemicals used on masks?

  • ISO 13485 for Class 1 FDA medical device

    What are the requirements if any for FDA class 1 medical device to comply with ISO 13485

  • ISO 13485:2016 clause 4.1.1 - documenting roles

    So far the templates have been helpful but have a question about ISO 13485:2016 clause 4.1.1 "The organization shall document the role(s) undertaken by the organization under the applicable regulatory requirement: My company manufactures and distributes...so exactly what am I documenting and how do I present it in good form?

  • Reducing number of documents for review

    How can we reduce the number of documents to be reviewed?

  • Integrated approach of ISO 13485 and ISO 9001

    1.An Integrated approach of ISO 13485 and ISO9001 What should be focused on considering these 2 standards (These will be audited separately). For integrated approach, I am following Anenxure B of ISO 13485

    2. How to pass ISO 9001 stage 1 and stage 2 audit?

    3. A Regulatory procedure and form is required that will meet both the standards requirements
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