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 moreWhat risk-based approach to QMS means?
The new version of the ISO 13485:2016 standard expects companies to apply a “risk-based approach” to all their QMS processes, exactly stating they […]
Read moreWriting ISO 13485 Quality Manual – Need a tip?
A quality manual is a document that outlines the company’s intentions for managing processes in quality management. It may include rules for […]
Read moreThe Importance of the Quality Manual in Medical Device Compliance
What Is a Quality Manual and Why Does It Matter? A Quality Manual is the foundation of a QMS—often called the “QMS […]
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