ISO-13485-blog

Tag: “measuring”

Calibration requirements in ISO 13485
Advisera Anita Joshi Anita Joshi
March 8, 2019
Blog
Manufacturing medical devices is a highly complex process, and calibration requirements according to ISO 13485 mean high precision and close...
Manufacturing medical devices is a highly complex process, and calibration requirements according to ISO 13485 mean high precision and close monitoring. The manufacture of medical devices makes use of various types of equipment and measuring...
read more
Related Products
Integrated EU MDR & ISO 13485 Toolkit
All Policies, Procedures, and Records
Learn more
ISO 13485 Toolkit
All Policies, Procedures, and Records
Learn more
ISO 13485 Foundations course
Accredited Online Training by Top Experts
Enroll now
Upcoming free webinar
Advisera Kristina Zvonar Brkic
Presenter
Kristina Zvonar Brkic
A How-to Guide for ISO 13485 Implementation
Thursday – June 1, 2023
Register now
Suggested reading
How to classify medical devices according to the EU MDR
Advisera Kristina Zvonar Brkic Kristina Zvonar Brkic
April 22, 2021
With the new Medical Device Regulation, it is important for medical device manufacturers...
read more
What are the EU MDR technical documentation structure and requirements?
Advisera Kristina Zvonar Brkic Kristina Zvonar Brkic
April 6, 2021
The main purpose of technical documentation in the EU Medical Device Regulation (MDR)...
read more
List of mandatory documents required by ISO 13485:2016
Advisera Strahinja Stojanovic Strahinja Stojanovic
January 18, 2017
The new ISO 13485 is based on ISO 9001:2008, which means that the...
read more