Show Articles for 'CLINICAL EVALUATION'

It’s no secret that clinical evaluation of existing data is mandatory for all medical devices and good practice (not to mention common sense) indicates it should be done before even starting a clinical investigation in humans. Many of us, even if we know the clinical arena inside-out, have found this process to be lengthy and sometimes not that straightforward at all! The European regulations are not the only ones requesting this process to be in place, it has become a worldwide approach for complying with essential principles for medical devices. The upcoming revision of the ISO 14155 now also includes the requirements in addition to many other regulatory documents throughout the world.

As most of you may know, ISO 14155 FDIS:2010 received 100% positive voting on the 9th of November 2010. However, that document has been withdrawn upon my request, because the final version contained editorial changes by the ISO central committee that did not retain the original meaning intended by the WG experts. Corrections have been requested and the document is being revised to reflect the...

The ISO 14155:2011 has recently been published with many new requirements compared to the previous version throughout the document. For companies conducting clinical investigations with medical devices currently following the 2003 version, updates will be needed as soon as the document is harmonized by the European Commission (expected Q3 2011).