QUALITY SYSTEM
Quality and Regulatory Compliance
The entire lifecycle of Dr Biolyse® technology, from its design to production, from clinical validation to post-market surveillance, is conducted within the framework of international standards and the most current legislation. Our quality management system is not merely a legal obligation; it is a corporate reflection of our scientific reliability and the priority we give to patient safety.
Legal Framework and Regulations
Our device is developed and certified in full compliance with the most current requirements of the European Union Medical Device Regulation (MDR). Regulation (EU) 2017/745 – Medical Device Regulation (MDR) 93/42/EEC – Medical Device Directive (MDD) (Within the scope of the transition period)
Quality Management System and Risk Management
Every stage of the product lifecycle is guaranteed by internationally recognized quality standards:
· EN ISO 13485:2016 – Quality Management System for Medical Devices
· EN ISO 9001:2015 – Quality Management System
· EN ISO 14971:2019 – Risk Management for Medical Devices
· ISO/TR 20416:2020 – Post-Market Surveillance (PMS)
Product Safety, Biocompatibility and Performance
As with every medical device that comes into contact with the patient, our safety and performance tests are subject to the strictest standards:
· IEC 60601-1 / IEC 60601-1-2 – Basic Safety and Electromagnetic Compatibility in Medical Electrical Equipment
· ISO 10993 Series – Biological Evaluation of Medical Devices
· IEC 60479 Series – Effects of Current on Human Beings and Livestock
· ISO 18458:2015 – Biomimetics – Terminology, Concepts and Methodology.
Clinical Research and Data Integrity
Our scientific validation processes are based on the highest ethical and methodological standards in clinical research:
· ISO 14155:2020 – Good Clinical Practice in Medical Devices (GCP)
· MEDDEV 2.7/1 Rev.4 – Clinical Evaluation Guidelines
· MEDDEV 2.12/1 Rev.8 and 2.12/2 Rev.2 – Vigilance and PMCF Guidelines
· MDCG 2020-6, 2020-13, 2020-7, 2020-8 – Clinical Evidence and PMCF Templates
Labeling, Software and Usability
The information and software interfaces provided with our device are also audited by international standards:
· EN ISO 15223-1 / EN ISO 20417 – Labeling, Symbols and Manufacturer Information
· IEC 62366-1 – Usability Engineering
· IEC 62304 – Medical Device Software Lifecycle Processes
· EN ISO 11607-1 – Sterile Packaging Rules
· EN ISO 27001 – Information Security and Cybersecurity
Environmental Responsibility
· EN ISO 14001:2015 – Environmental Management System
· 2012/19/EU – WEEE Directive (Waste Electrical and Electronic Equipment)