Translating the regulatory landscape of medical devices to create fit-for-purpose artificial intelligence (AI) cytometry solutions
February 23, 2024
February 28, 2024.
[NEWS] Company
We are proud to announce that we have received the renewal of our Quality Management System Certification based on the international standard NF EN ISO 13485:2016.
This significant achievement has been certified and renewed by GMED (Groupement pour l’évaluation des dispositifs médicaux), attesting that our quality management system meets the rigorous requirements set forth for medical devices.
What is ISO 13485:2016?
ISO 13485:2016 is an internationally recognized standard that outlines the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard is particularly important for organizations involved in the production of in vitro diagnostic medical devices, as it ensures that products consistently meet customer and regulatory requirements.
Benefits of ISO Certification for METAFORA
Achieving ISO 13485:2016 certification brings numerous benefits to METAFORA and our stakeholders:
Enhanced Quality Assurance: The certification demonstrates our commitment to maintaining high-quality standards in our products and services, which is crucial in the medical field.
Regulatory Compliance: Meeting the requirements of this international standard ensures that our processes comply with relevant regulations, facilitating smoother interactions with regulatory bodies.
Increased Market Credibility: ISO certification enhances our reputation in the industry, instilling confidence in our customers and partners regarding the quality and safety of our diagnostic medical devices.
Improved Operational Efficiency: Implementing a quality management system helps streamline processes, reducing waste and improving overall efficiency within our organization.
About GMED
GMED is a French notified body (0459) responsible for the conformity assessment of medical devices in accordance with Regulations (EU) 2017/745 and (EU) 2017/746, as well as applicable European directives (90/385/EEC, 93/42/EEC, and 98/79/EC). It is also an international reference organization for the certification of quality management systems in the health and medical device sectors according to ISO 9001, NF EN ISO 13485, ISO 13485, and BS EN ISO 13485.
Commitment to Quality
At METAFORA, we are dedicated to the continuous improvement of our quality management system. The ISO 13485:2016 certification not only reflects our current capabilities but also sets the foundation for future growth and innovation in the field of in vitro diagnostics.
We are excited about the opportunities this renewed certification brings and remain committed to enhancing the lives of patients through our high-quality diagnostic solutions. Thank you for your continued support as we strive for excellence in everything we do!
