Quality Management.
Legal and planning certainty throughout the entire product lifecycle.
We are certified to DIN EN ISO 13485
Our high, monitored quality standards, based on our quality management system, guarantee the high quality of your products and solutions. On request, we naturally also develop and manufacture all non-medical products to high quality standards.
What this includes
- Support with and performance of risk analyses and risk management
- Preparation of standards-compliant development documentation
- Test-driven and validated software development
- Validated AI in medical devices
- Certified processes for validating AI in medical devices
- Pre-compliance testing during development, including AI
Audit readiness through applied standards
Quality management
Risk management
Usability
Software life cycle
Cybersecurity
Electrical safety
Data protection
Medical Device Regulation
News
Intelligent post-market surveillance software for medical device manufacturers
Market launch of an intelligent post-market surveillance software for medical device manufacturers – funded under the funding guideline “Markteinführung Zuschuss EFRE 2021 bis 2027”.
Co-funded by the European Union.
More about the funded projectAI-supported QM software as SaaS
Market launch of AI-supported software for QM and for managing regulatory requirements under the MDR and DIN EN ISO 13485, as SaaS.
Co-funded by the European Union.
More about the funded project