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Regulatory Services

Unlock success in regulatory compliance for medical devices with tailored, hands-on guidance

Expert guidance for starters

Customized workshops and hands-on guidance in the topics:

  • Understand medical device basics such as requirements of regulation (EU) 2017/745 on medical devices (MDR), EN ISO 13485 and many more
  • Assess regulatory requirements for Software as a Medical Device (SaMD), and software lifecycle processes aligned with EN 62304
  • Participate in interactive exercises to determine if your product qualifies as a medical device
  • Gain insight into how risk management influences your product development strategy
  • Overcome hurdles related to clinical evaluation / clinical studies
  • Create your roadmap to CE marking


Expert guidance to certification

  • Strategic regulatory consulting for the development and maintenance of medical devices, gap analysis, performing mock-audits
  • Assistance in the implementation of a quality management system according to EN ISO 13485 and MDR
  • Guidance in the preparation of the Technical Documentation (TD), review of promotional material, actor and product registration in EUDAMED
  • Regulatory support for performance of clinical studies (study protocol/ethics, data management, statistics, medical writing, GCP)


Our expertise

  • We are a medical device manufacturer and have already successfully navigated our way through the MDR.
  • We have >10 years of regulatory experience in the field of medical device development including SaMD.
  • Strong GLP/GCP background in the field of bioanalytical laboratory, clinical data management and statistics, medical writing
  • Network with the Medical University Graz


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