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Risk based approach in ISO 13485

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Guest user Created:   Jun 12, 2020 Last commented:   Jun 12, 2020

Risk based approach in ISO 13485

1. Has there been a noticeable improvement with the implementation of 13485:2016 with the risk-based thinking approach?

2. What must companies do in advance to prepare for the stringent requirements in Eu MDR handling of complaints? 

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jun 12, 2020
1. Has there been a noticeable improvement with the implementation of 13485:2016 with the risk-based thinking approach?

Since we are not a consulting company, unfortunately, we really do not have feedback from the field about this matter. But, when we discuss with the client that has both our toolkit, it is noted that the risk-based approach helped them in making individual decisions. For example, when defining critical suppliers and making a decision with which to establish a quality agreement and with which not; then when determining when to go to the audit of a critical supplier - whether once a year or less often or more often; then, which software needs to be validated etc. 

More information about the risk-based approach you can find in the following article:

2. What must companies do in advance to prepare for the stringent requirements in Eu MDR handling of complaints?

First of all, you need to learn about MDR requirements. On this link, you can find Full text of EU MDR (Medical Device Regulation): https://advisera.com/13485academy/mdr/ 

Then it will be best to check which additional documentation you need to have to be in compliance with the MDR and to compare it with your current status.

Complete EU MDR Checklist of Mandatory Documents you can find on the following link: https://info.advisera.com/13485academy/free-download/eu-mdr-checklist-of-mandatory-documents

Once you have identified which documents these are, they need to be prepared.

How templates for the Clinical Evaluation, Post-market surveillance system and Technical file look like you can see in our ISO 13485 & MDR Integrated Documentation Toolkit: https://advisera.com/13485academy/iso-13485-eu-mdr-documentation-toolkit/

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Jun 12, 2020

Jun 12, 2020