iV PASS is a regulatory consulting company dedicated exclusively to In Vitro Diagnostic Medical Devices.

Our mission is to assist our clients in their regulatory strategy, and to provide regulatory writing, audit and training services for CE MARKING of IVDMDs manufactured on an industrial scale, and for regulatory compliance of IVDMDs manufactured and used on a non-industrial scale by health institutions.

Expertise Areas

TECHNICAL DOCUMENTATION REGULATORY COMPLIANCE

QMS REGULATORY COMPLIANCE

Central Regulations

REGULATION (EU) 2017/746

DIRECTIVE 98/79/EC

Our services 

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Strategy

  • Selection of the notified bodies
  • Product classification determination
  • CE marking conformity assessment procedure determination
  • QMS documentation content determination
  • Design of the performance studies
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Implementation

  • GAP analysis between existing and required documentation
  • Technical documentation writing, including but not limited to:
    – Clinical Evidence Report
    – Performance Evaluation Plan & Report
    – Literature Search Plan & Report
    – Scientific Validity Report
    – Analytical Performance Report
    – Clinical Performance Report
    – Post-market Performance Plan & Report
    – Stability report
  • QMS documentation writing, including but not limited to:
    – Quality manual
    – SOPs
    – Record templates
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Training

  • Face-to-face or online
  • Customized to client needs

Contact iV PASS and start your regulatory journey.

Latest news

(FRENCH) iV PASS et MD101 co-présentent ce webinar sur l’impact de la mise en application du règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro sur les dispositifs « maison » utilisés dans les établissements de santé. Accéder au webinar : https://www.youtube.com/watch?v=-xvkwZTCt04&feature=youtu.be
iV PASS is thrilled to announce that Michelle LEE, is joining our team as Executive Assistante in Australia. She brings extensive experience as Executive Assistant and Project Manager. She will be a key asset for implementing iV PASS IVD regulatory activities in Australia. Welcome to iV […]
(FRENCH) iV PASS et MD101 co-présentent ce webinar sur l’évaluation des performances des DMDIV conformément au Règlement (UE) 2017/746. Accéder au webinar : https://www.youtube.com/watch?v=iLnVCRD-8PI
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