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  • Risk Analysis

    I am working for a medical device distributor and retailer company which is one of the biggest retailers in XYZ. We have decided to have a QMS and ISO 13485 certificate. Firstly, we tried the understand department processes after that we want to know control points in our system. Then we will work for procedures, instructions, lists, and forms. I want to implement an effective risk management system for the current situation. I need to know that what is your suggested way for following issues. creating a team for QMS and also risk management, defining risk management plan, risk assessment methodology, risk analysis, implementation of risk control measures, risk and benefit analysis detection of failures, reports. I have your premium preview about risk management and hazard procedures and related documents. If I buy the Premium document, can I find the way of doing the business? I know ways are depending the organization. However, the methodology and doing business about risk assessment for medical device retailers can be the same. I trust your experiences. What is your advice about the situation? Thank you very much, best regards.
  • Change management

     I am checking your documents now, but I can't find anything about change management which is referred by 4.1.4 of the 13485.

    Could you please advise me how will we show the compliance of this article in our QMS system? A 13485 QMS require a change management procedure or not? If not how we will comply with this article?

  • Lab equipment and instruments

    Hello :) I have questions, please.
    1. I was wondering if you know if the ISO 13485 also covers lab equipment and instrumentation?
    2. Should we have to have the lab equipment at the same QMS standard do you know? under the 13485
  • ISO 13486:2016 certification for a machine

    I have bought a medical-grade machine which has ISO 13486 - 2016 certification. Is it possible for me to get a copy of this certification to display in my clinic?
  • 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?
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