aca24@aca-pharma.de/

+49 341 33 73 33 60

Product categories

  • • In vitro diagnostics

Project initiation

  • • Medical device justification, borderline
  •    assessments, product classification
  •    according to new Medical Device Regulation
  •    (MDR) and In Vitro Device Regulation (IVDR)

Regulatory advice

  • • Scientific and strategic advice
  • • Selection of notified bodies and competent
  •    authorities

Market entry strategies

  • • Market analysis
  • • Building up marketing and sales

CE Marking

  • • Product conformity assessment
  • • Gap Analysis and Update of existing Technical
  •    Documentation to the new Medical Device
  •    Regulation (MDR) and In Vitro Device Regulation
  •    (IVDR)
  • • Compilation of Technical Documentation
  • • Establishment of an appropriate Post Marketing
  •    Surveillance and Vigilance System

Project development

  • • Project management
  • • Proof of product quality
  • • Data base searches, retrieval and evaluation
  •    of literature
  • • Data gap analysis
  • • Initiation and monitoring of safety studies
  • • Biocompatibility evaluation according to
  •    EN ISO 10993
  • • Analysis of the requirements set by the
  •    competent national authority and the
  •    Notified Body (NB)
  • • Design and analysis of the performance
  •    evaluation
  • • Preparation, up-dating and maintenance of
  •    Clinical Evaluation Report according to
  •    MEDDEV 2.7/1 rev. 4
  • • Establishment, up-dating and maintenance of a
  •   Quality Management system according to EN ISO
  •   13485 as well as a Risk Management system
  •   according to EN ISO 14971
  • • Support in audit preparation and accompaniment
  •    through audits

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