You Develop Medical Devices - We Handle The Rest
Our business areas - expertise for the success of your medical devices In a constantly changing and highly regulated industry, our team of experts offers customized solutions to bring your medical devices to market safely and efficiently. Our services include:
Regulatory Affairs for Medical Devices
We support you in meeting regulatory requirements worldwide:
- Technical documentation (EU, USA, global)
- International approvals, including US FDA
- Electrical safety according to EN 60601 series
- Standards assessments
- Risk management
- Usability validation (IEC 62366-1)
- Market access
- Software compliance (ISO 62304)
Regulatory Affairs for IVDs, Combination Products and Tissue/Substance-Based Medical Devices
Our expertise covers the regulatory and technical requirements for these special product categories:
- ISO 13485, IVDR and 21 CFR 820
- Strategies for market access
- Preparation and maintenance of technical documentation
- Biological evaluation (ISO 10993 series)
- Toxicological analyses
- Requirements for in-house devices
- Combination products and substance-based medical devices
- Processing of animal tissues (ISO 22442 series)
- Sterilization process validation
- Risk management and usability validation (IEC 62366-1)
- Products such as implants and sterile medical devices
Management Systems
Efficient management systems are the key to sustainable success:
- Implementation and optimization of ISO 13485, MDR and 21 CFR 820
- MDSAP certifications
- ISO 27001 for data security and data protection
- ISO 9001 for quality management
- Implementation of audits
- Support with reimbursement procedures
Clinical Affairs
Our team accompanies you through the entire clinical life cycle of your products:
- Systematic literature research and state of the art analyses
- Development of clinical strategies and plans
- Creation of clinical development and investigation plans
- Conducting user surveys
- Clinical and performance evaluation
- Preparation of PMCF and PMS plans and reports, including PSURs
- Writing safety reports and performance summaries (SSCP)
With our in-depth expertise and practice-oriented advice, we offer you comprehensive support to successfully position your products. Contact us for an individual consultation!
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