This is the first of a series of articles on conducting a root cause investigation. The model applies to a Corrective Action/ Preventive Action or CAPA investigation, as well as any other type of investigation. In this premier article, we describe a model for conducting a science-based, systematic investigation leaving future articles to delve into more detail as the individual steps are explored, specific tools are highlighted, and example investigations are reviewed.
Part I in a series of articles that will provide insight into TSP, its applicability to the medical device industry, and how it helps achieve the high level of software quality required for devices.
There’s just one takeaway from this week: If your organization already has a QMS premised on EN ISO 13485:2003, then you probably already comply. However, if your organization has identified design and development or product realization as excluded or not applicable within the Quality Manual, then it becomes; “Captain I think we have a problem!”
IVD device manufacturers should always be aware of obscure and not so obscure changes made to the IVDD and Directives as a whole, especially with more changes to the IVDD being planned.
Article 5 of the IVDD is all about the presumption of IVD medical devices complying with their essential requirements and the only sure-fire way to ensure compliance is achieved is through the application of harmonized standards and common technical specifications.
This edition has two important takeaways: one, without a CE mark, the device cannot enter into commerce in the EEC; and two, the language requirement will continue to be a big challenge for device manufacturers as more countries opt to have labeling and IFUs in their native tongues.
The path toward conforming to essential requirements begins with a robust design and development process that ultimately results in an IVD medical device that is safe and effective in its intended use.
Article 2 of the IVDD establishes the salient requirements with which IVD devices need to comply to gain entry into the EU. Remember, there is no such thing as minimum compliance, or maximum compliance; it’s just compliance.
There are four fundamental differences associated with Article 1 of the IVDD versus the MDD. It is incumbent upon device manufacturers to comprehend these fundamental differences along with definitions specific to the IVDD to support the successful entry of in-vitro devices into the European market.
This series of articles will be premised on the IVDD.The primary takeaway from this week’s edition is that there are significant similarities between the MDD and the IVDD. However, there are also several differences that make the IVDD appear quirky. With revisions to the IVDD looming on the horizon, ongoing compliance with this Directive will continue to be a challenge.
