How can we help?
- Regulatory expert support for the planning and creation of the necessary processes and documentation.
- QMS and technical documentation updates
- Support in CE marking activities
- Training and workshops on the effects of the IVDR on in-house developed tests.
- The digital Entries tool for defining the applicable requirements of the IVDR for the laboratory professionals in a matter of minutes.
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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
