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Product categories

  • In vitro diagnostics

Project initiation

  • Medical device justification, borderline assessments, product classification
  • according to new Medical Device Regulation (MDR) an dIn 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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