How can we help?
- Writing the risk management process description in accordance with applicable standards and regulations
- Implementing and maintaining the risk management process
- Preparing risk management plans and reports
- Covering all risk analysis aspects (e.g., mfg processes, quality processes, design, usability, software, cybersecurity)
- Determination of benefit-risk
- Answering the risk management related questions raised by notified bodies and authorities
- Offering customized and open training for medical device risk management
Electrical Safety IEC 60601
IEC 60601-1 is the basic international safety standard for medical electrical devices and systems.
Biological Safety ISO 10993
International standard of biological safety evaluation process and preparing biological evaluation documentation for medical device manufacturers.
IVD Performance Evaluation
In vitro diagnostic medical device (IVD) regulations are set out in the EU In Vitro Diagnostics Regulation.
Qualification and classification of medical devices
Our team’s versatile experience and the available tools help in bringing clarity to the challenging cases.
Regulatory plans
Regulatory plans for medical device manufacturers.
IVDR compliance for in-house developed tests
Laboratories developing IVDs in-house must maintain Technical Documentation and Quality Management Systems to comply with the IVDR and the national law.
Medical software
Adhering to medical device software regulations throughout the entire lifecycle.
Risk Management ISO 14971
Setting up and implementing a risk management system and preparing risk management documentation.
Introducing Aurevia
New EQA schemes for 2025
Patient Safety: The Cornerstone of Healthcare
EQA Program 2025
