QFI is a leading provider of scientific and clinical literature research on medical devices. We produce high-calibre grounded-theory, thematic and phenomenological publication quality clinical evaluations designed to fulfil medical devices clinical data by literature search and critical examination.
Whether using available clinical evaluation templates belonging to your organisation or producing our own, expert report, we are adept in fast, term-key results complying with various medical legislation. Notably, QFI produces clinical data by literature search according to Council Directive 93/42/EEC and MEDDEV 2.7/1 revision 4 and Regulation (EU) 2017/745, however, we also produce such research on active implantable medical devices and performance evaluation research on in vitro
Our technical specialists search literature databases a client specifies and uses. Alternatively, we utilise and exploit from approximately 40 databases and research libraries.
Depending on precise client requirements, QFI also produces:
- Clinical evaluation plans
- Overall medical device clinical strategies
- Clinical regulatory plans
- Clinical development plans
plus a range of protocols, eg
- Literature search protocols
- Clinical evaluation appraisal plans
- Clinical evaluation assessment plans
leading to final evaluation reports, executive summaries and as required, presentations and posters.
Where instructed, we are able to determine conformity with mandatory and variable essential requirements/ general safety and performance requirements requiring clinical evidence of clinical safety and performance.