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  • Software validation process and Risk Management procedure

    I have a few questions in regards to 13485. Please find them below:

    1. 4.1.6 What software needs to follow the software validation process? Would smartsheet or excel have to be validated?
    2. We do not only manufacture medical-related products. We produce thermoplastics. Is it ok for us not to use a risk management procedure on non-medical if specifically called out in the procedure? 

  • FDA / GMP guidelines

    In the guidelines, it is not clear when you need cleanroom facilities destined in FDA / GMP guidelines.

  • KPI vs Quality Objective

    What is the difference between a KPI and a quality objective? What should quality objectives be like under ISO13485, and how many does a company need to have to meet standard requirements

  • Service-Only Providers and ISO 13485

    This ISO always refers to "medical device manufacturers." XYZ and numerous other independent service providers do NOT manufacture, but we repair and maintain medical equipment. In your nomenclature, "service provision" is always coupled with "production." How does a service-only provider gain ISO13485 certification exclusive of the manufacturing provisions? Is this ISO even appropriate given that XYZ is NOT a manufacturer? We are in the early stages of seeking counsel on the project, and we want to get it right.

  • Technical File

    I need your help to develop a technical file for medical devices. Will you please let me know about the contents and kind of information that could be a part of the technical file. If possible please send me a specimen.

  • Design and development and requirements of 7.1

    I'm establishing the QMS according to ISO 13485, I have been thinking about the change control, have to define the change control of design and development and other changes occurring during production days. Another question, how do you understand the requirements of 7.1? How to put them into practice?

  • Quality Agreement template

    I purchased the documents toolkit for 13485 and 14971, but I notice there is no Quality Agreement template in it for our vendors. Do you have one of those?

  • Getting ISO 13485

    So to make a long story short, we are basically promised more work if we have ISO 13485 on our belt. In reading the standard I find that it really doesn’t apply to us. We do not do any sterilization, assembly, servicing, design, installation, particular requirements of implantable devices, CFR regulations, special labeling and traceability for medical devices. We do have a Clean Room where we mold medical products that has compliant procedures, risk assessments and so forth.

    XYZ is a small rubber molding manufacturer (33 people) certified to ISO9001:2015 with the exclusion of Design. We manufacture for the Government, Aerospace, Military, Commercial and Medical fields. We manufacture small o-rings and core seals to medical manufacturer that typically ships in bulk with no major requirements such as CFA, FDA, labeling, etc.

    So my question, is it a norm for a manufacturer to be ISO 9001 certified with an emphasis on ISO 13485? Getting ISO 13485 with so many exclusions or at least half of the standard doesn’t seem right.

  • Processes and records for CE purposes

    We are currently using the templates to design our ISO 13485 processes, primarily to apply for CE under the MDR of our new medical device. In the light of this, you could help me out with the following.
    • We designed this medical device together with an engineer of a foreign medical device production facility, which is already ISO13485 compliant.
    • The product will only be produced for us, with our name on it. Some sort of Own Brand Labelling (OBL), but not completely the same.
    • Based on the relevant risk classification rules, we classified the medical device in risk class IIa.
    • We will have full access to all information and data needed to construct the technical file.
    My question:
    1. Are there any ISO13485 processes and records in the template kit that would not be necessary for CE purposes, or would all be necessary, taking into account risk class IIa?
    2. How would an auditor exactly assess the implementation and operating effectiveness of these processes? I would guess according to the corresponding records, but how do they assess whether all records are in place for all cases that a record had to be registered?

  • Customer feedback

    For class III medical devices, looking for guidance to understand what are the responsibilities of a distributor having a full process, from storage and delivery to clinical use activities such as user training and proctoring. this will help me to write a proper quality agreement.
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