Product Development Process Safeguards
Viewing product development from purely a calendar perspective will limit the real view of success.
IVDD – Article 9
Understanding the significance of Article 9 and correctly classifying a device will drive the entire qualification process by identifying the appropriate Annexes needed to support the testing and application of IVD medical devices.
IVDD – Article 8
IVD medical device manufacturers that fail to act quickly in regards to addressing issues associated with bad devices, will be on the receiving end of the splenetic tone coming from each of the Member States from their respective Competent Authorities.
Miniaturization – Small is Beautiful, Beneficial
While an apple a day may not always keep the doctor away, a wireless patient monitor just might.
IVDD – Articles 6 & 7
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.
IVDD – Article 5
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.
Biomimicry Lessons from Sharks
Apart from Speedo swimsuits, what other biomimicry learnings from Shark skin can we use for medical devices?
IVDD – Article 4
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.
IVDD – Article 3
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.
Missing Something Important?
Involving all aspects of ergonomics—physical, cognitive and emotional—is the only way to create tomorrow’s engaging, enjoyable and appropriate device experiences, while fulfilling functional requirements as well as intangible needs.
