If a medical device establishment is manufacturing sterile medical devices, make sure that environmental monitoring and the calibration and servicing of environmental control systems are part of the product realization equation.
When two highly respected companies like Abbott and Johnson & Johnson get caught up in recalls, we are reminded that thorough verification and validation are fundamental to successful medical device development.
In this third of a series of articles on conducting a root cause investigation, we explore a second key investment every investigator should make: assuring you have the facts! Unfortunately, investigators are often under tremendous pressure to complete the investigation and assume the information they have is entirely correct. As a result days, or weeks, are wasted going down the wrong path.
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.