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
Research groups
Downloads
Shareholdings & Funding
Das sagen unsere Kunden
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