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

  • CE mark and ISO 13485 for medical device in EU

    Is it necessary to be ISO 13485:2016 certified before pursuing the CE Marking? Or is having the ISO 13485 more of a benefit, and not a requirement.

  • Quality objectives or KPI in QMS Manual?

    Hi. Just wanna know if the declared procedures in our QMS Manual should always have a Quality Objectives? Or is it just okay to have a KPI for whole department? Thanks a lot.

  • What are minimum personal/roles for the new company per ISO 13485?

    What are minimum personal/roles for the new company per ISO 13485?

  • Applicable standards to comply

    If my company is working on providing services (etc lab imaging services), which standard should we be certified on ? Do we still need ISO 13485?

  • Product Realization requirements for distribution and manufacturing facility

    I am currently doing an ISO 13485 system for the first time. I have several years of experience in ISO 9001 and EHS but need help in 13485 please.

  • Applicable ISO Standards for Sterilization

    Dear Sir, I work as an engineer in a research laboratory for SGS. I am contacting you because we are currently running a project about microwave sterilization. Can you please help me finding a way to have access to all ISO norms about microwave sterilization or sterilization in general? Are they available online?

  • QMS set up for manufacture of medical device

    Hi,

  • Compliance with ISO 13485 or GMP for Class III device

    Hello, There is a requirement for planning the plant for medical device class 3 production(dermal filler) another than ISO 13845? The plant will be under demand of ISO 13845 or under GMP demand? In Europe.

  • Submission of Non-conformity Report

    I work at a company here in Brasil.We are ISO 13485 certified and I would like to know where do we have to send the nonconformities report. It is written that the Recipient must be the National Competent Authority (NCA).

  • Complaint Handling in ISO 13485

    Hi, looking at your page regarding complaint handling for ISO13485:2016 but the article didn't state what section it was in? In 2003 it was part of 8.5.1 but there is no talk of complaints in 8.5.1 in the 2016 standard.
Page 63 of 66 pages