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  • Validation requirements for 13485

    What is the validation requirements for 13485, we make medical devices (injection moulding) and assembly?

  • Sterile Instruments Packaging

    I wanted to know if there is anything mentioned about Sterile packaging changing its color in ISO 13485?
    Like we make Electro Surgical instruments and some of our sterile products' packaging changed its color a little from pink not entirely.
    The packaging we used had a little issue of ink, so it didn't change its color to entirely yellow/gold as mentioned on the packaging but it did change from its original pink color.
    Can you please guide me about this issue?

  • First in Human Feasibility Study (4 to 8 patients) conducted prior to ISO 13485 Certification

    Can a First in Human Feasibility Study (4 to 8 patients) be conducted prior to ISO 13485 Certification?

  • ISO 13485 Servicing vs FDA refurbishment of medical devices

    Is there a difference between ISO 13485 definition of servicing and FDA definition of refurbishment of medical devices?

  • Requirements for Medical Gown Production under ISO 13485

    I would like to find out if there are any requirements for Medical Gown Production under ISO 13485 especially the production environment criteria. Which level of clean room should be adhered to?

  • ISO 13485 compatibility with EN 14126

    Is ISO 13485 compatible with EN14126?

  • Requirement of mentioning details of outsourced process in Clause 4.1.5 of ISO 13485

    In the clause 4.1.5 of ISO 13485 (which talks about the outsourcing of any process by an organization), is it required to mention details of the outsourced process while drafting the document? And, can you elaborate on the controlling and documentation of such a process? If you can provide an example of how an organization documents clause 4 for the ISO 13485.

  • Objectives for Textile Unit manufacturing isolation gowns

    What Objectives can we have for a Textile Unit manufacturing ISOLATION GOWNS?

  • Effect of medical device class on ISO 13485 documentation

    1. I would like to know how the class of a medical device affect in the documentation required to implement a quality management system according to ISO13485:2016.  

    2. I mean if we manufacturing the medical device of class IIa (specifically a gamma probe) what type of certifications should have it. (IEC60601 for electromedical equipment, electromagnetic compatibility, among other).

    3. It's possible to know all documentation that is necessary for design and manufacturing gamma probes? thanks 

  • Evolving QMS system of home blood test kit

    We need to evolve a QMS system of our home blood test kit, which included a specimen collection device. We need to produce a Declaration of Conformity and be CE ASAP. What is the quickest way to go about this?
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