Quality Management System ISO 13485
US FDA 21 CFR Title 820 (QSR)
We know quality systems, including the USA Food and Drug Administration Quality System Regulation, QSR, 21 CFR Title 820.
QMS Improvement and Gap Analysis
Improvement of medical device manufacturer’s quality management system (QMS) and GAP analysis.
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.
