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.
If you’ve been struggling to work out the strategy or the methodology and generally putting things off, you might want to consider improving your proficiency by gaining additional expertise by checking out WMDO’s new course on: "Clinical Evaluation for Market Approval and Clinical Trials"
This intensely comprehensive 3 course suite provides you with the essential information, requirements and guidelines you need to successfully and accurately conduct clinical evaluation under the new European Directives. From regulatory process and compliance to literature review and conformity; forget those sleepless nights and get on the right track to market approval today.