Search results

Home / Search

Category:
Select
Select

11270 results

Guest

Guest

Create New Topic As guest or Sign in

HTML tags are not allowed

Select

Assign topic to the user

  • Requirement of ISO 13485 for manufacturing of semi-finished product

    Yes, you need to prove that your prosthetic liner is biocompatible with the human body. To prove it, you need to perform certain tests according to the ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process. Guidance on which tests you need to perform you can find in Annex A of this standard. The number and scope of tests will depend on the length of contact of the medical device with the skin, the type of contact, and the like. 

    Considering the test for durability, you need to prove how long your product is stable when using in compliance with instructions of use. This includes, for example: how long the prosthesis is worn during the day, whether it is properly maintained, whether it is left somewhere in the strong sun or not.

    As for testing, I don’t know what part of the world you’re in. If you are in Europe, there is a whole chain of Eurofins labs that do different tests, so you can ask them.

  • ISO 13485 requirements for outsourced processes under MDR

    Hi, my question concerns companies that provide sales, service, repair, and installation services to customers. Obviously, they don't have control over the outsourced process, as it can only be justified by legal manufacturer, not distributors. Do you have any advice for managing the outsourced process in such cases? Also, I would appreciate it if you could point out any specific regulation under UKMDR that would be applicable to this matter.

  • Integration suggestion on QMS (AS9100) & ISMS (27001)

    Inclusions and exclusions in the scope of ISMS will depend on the information, your organization wants to protect.
    You need to identify in which part of your company is your most valuable information - see the details here: How to define the ISMS scope https://advisera.com/27001academy/knowledgebase/how-to-define-the-isms-scope/

    For example, if the most important information is about new products, then the Research & Development process/department must be in the scope. If the most important information is about customers, then the Customer support process/department must be in the scope. You can also define all the organization's information as part of the ISMS scope.

    This article can provide you further answer about integrating management systems (the general concept applies to your case):

    These materials will also help you regarding scope definition:

  • Certified company not taking the audit comments

    Thank you for sharing about 4 effective risk mitigation strategies, these will be really helpful for me. I love reading this blog; it talks so much about planning a great idea about it. Keep sharing such informative articles in future, will be appreciated. See @ https://parapet.com/Solution****************************

  • How to report to senior management

    ISO 9001:2015 does not prescribe a specific method. Clause 7.4 mentions the use of:

    • what to communicate;
    • when to communicate
    • with whom to communicate;
    • how to communicate;
    • who communicates.

    So, about communicating to senior management we need to decide first what do they want or need to receive. Perhaps:

    • performance information about processes and the whole management system;
    • sales performance information;
    • complaints information;
    • costs information;
    • defects information;
    • customer satisfaction information

    Then, decide frequency, the when: Weekly? Monthly? Quarterly?

    And the how – Meeting report? Special report? Digital dashboard?

    The following material will provide you information about communication:

  • Incorporation of conformity assessment in QMS

    Conformity assessment is a process that is used to demonstrate that a product meets specified requirements. In the case of medical devices, it means that conformity assessment is a process of demonstrating whether the requirements of MDD (93/42/EEC) or MDR (2017/745) relating to the device have been fulfilled. So, all documentation, tests, and reports according to the applicable regulations need to be done. It means that you need to define your processes in the way to collect all of it. 

    Here you have a direct link to Annex 9 of the MDR

Page 382-vs-13485 of 1127 pages

Didn’t find an answer?

Start a new topic and get direct answers from the Expert Advice Community.

CREATE NEW TOPIC +