CLINICAL EVALUATION PROGRAMME
QFI specialises in devising and producing high-calibre clinical data to fulfil European and other medical device legislation. Our clinical evaluation programme offers full package of evidence to fulfil Regulation (EU) 2017/745 as well as Council Directives 90/385/EEC and 93/42/EEC.
Our experienced specialists formulate clinical evaluation plans, guide sub-ordinate clinical development and complement these by robust evidence-based research linked to compliant market surveillance system elements.
QFI produces a wide range of scientific and clinical evaluations, from grounded-theory, thematic and phenomenological hypotheses to define post-market clinical follow-up and related studies. We also support these activities by improving manufacture’s clinical evaluation processes and procedures. Where instructed, our Clinical Trial Program completes the full complement manufacturers might require.
QFI can also produce clinical evaluation using a client’s own templates and proformas. We are adept and lead the way in clinical evaluation according to MEDDEV and IMDRF guides, including attending to asymmetric information, device equivalence criteria development and resolving older or background medicine medical devices just as adeptly as state scientiae and leading-edge technology and treatments.