Explained: Planning of product realization in ISO 13485 (Part 2)
In the ISO 13485:2016 standard is written what should be included in the planning of product realization in the chapter under this […]
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Explained: Planning of product realization in ISO 13485:2016 (part 1)
This chapter of the standards explains how one medical device company designs, develops, maintains and delivers medical device products. It covers the […]
Read moreWhat are Product Review Requirements as per ISO 13485
The purpose of the requirements review related to the product is to make sure companies keep to a high standard when it […]
Read moreWhat are the Outputs of Design and Development
The ISO 13485 standard requires the medical device company to define expected outputs in the end of any development stage. Design and […]
Read moreInfrastructure requirements in ISO 13485
Infrastructure in ISO 13485 is meant workspaces, process equipment, buildings, etc. Said in other words, to manufacture, design, or supply any medical […]
Read moreHuman resources in ISO 13485
This part of the standard explains how employees whose actions impact product quality that has to be qualified to work on products […]
Read moreCan my medical device be produced by a non-ISO 13485 certified manufacturer?
To have or not to have? To certify or not? You want to produce a medical device. So, you decide to hire […]
Read moreThere is a better way to organize your folders!
Small businesses collect numerous kinds of information – financial, employees, customers, vendors, etc. Traditional file organization describes storing data in paper files, […]
Read moreFrom paper-based to eQMS – Problem naming files
Sustaining a paper-based quality management system is pretty hard and time-consuming since it takes a lot of energy to find the essential […]
Read moreWant to apply risk-based thinking? This you should know
ISO 13485:2016 requires companies to use risk-based thinking to manage their business. Risk is inherent in all aspects of a QMS. There […]
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