SPRING DISCOUNT
Get 30% off on toolkits, course exams, and Conformio yearly plans.
Limited-time offer – ends April 25, 2024
Use promo code:
SPRING30

ISO 13485 & EU MDR - Expert Advice Community

Home / ISO 13485 & EU MDR

Discussions

Top Contributors

Expert

Rhand Leal

4148
Discussions
Expert

Carlos Pereira da Cruz

1916
Discussions
Expert

Dejan Kosutic

365
Discussions

Most Popular Tags

Product: Conformio Product: ISO 27001 Documentation Toolkit Product: ISO 13485 & MDR Integrated Documentation Toolkit ISO 27001 ISO 9001 Product: ISO 27001 & ISO 22301 Premium Documentation Toolkit Risk Assessment Product: ISO 13485 Documentation Toolkit ISMS register of requirements Internal Audit Product: ISO 27001/Risk Assessment Table Product: ISO 27001 & ISO 27017 & ISO 27018 Cloud Documentation Toolkit Certification ISO 14001
Select
CREATE NEW TOPIC +
Guest

Guest

Create New Topic As guest or Sign in

HTML tags are not allowed

Select

Assign topic to the user

  • 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?

  • 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?
Page 54 of 66 pages