The quick answer to this question is a Common Specification (CS): “means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.”1 Essentially, the European Commission has reserved the right within both EU MDR1 and EU IVDR5 […]
What are Common Specifications under EU MDR and IVDR? Read More »
The quick answer to this question is a harmonized standard (or “harmonised” standard in EU regulations), “means a European standard adopted on the basis of a request made by the Commission for the application of Union harmonization legislation”1. While this sheds some light on the title question, in this post, I will answer in a
What are harmonized standards under EU MDR and EU IVDR? Read More »
If your organization currently markets or plans to market medical devices within the EU, you may be wondering if EU MDR1 or EU IVDR2 requires on-site audits of your suppliers. EU MDR/EU IVDR does require notified bodies to consider the need for both announced and unannounced audits of your suppliers depending on risks associated with
There is a long list of requirements, procedures, activities, or arrangements that you’re obliged to document to establish a quality management system that is compliant with ISO 13485 and FDA 21 CFR 820. For many of the requirements, the standard/regulation just requires them to be documented while for others the need for a documented procedure
List of Mandatory Documents for ISO 13485 & FDA 21 CFR 820 Compliance Read More »
In this post, we investigate the importance of verb choice within Quality Management System (QMS) procedures and work instructions. We will look at: All this and more to help you have a great result during your next audit or inspection! To get us started let’s look at what ISO 13485 has to say about the
Quality Management System Procedures | Does verb choice matter? Read More »
