SmartMed has received ISO 13485 certification for its quality management system (QMS) for medical devices. ISO 13485 is an internationally recognized quality standard designed specifically to ensure the safety and effectiveness of medical device manufacturing processes and minimize risks to patients.
SmartMed has successfully completed the certification audit by a reputable Notified Body, demonstrating that it has established and maintains a QMS that meets all the requirements of the ISO 13485:2016 standard. "We are proud of the robust systems our team has built that ensure strict control over development and continuous improvement processes," said Beatriz Laranjeiro, SmartMed's QARA Officer and PRRC. "This certification demonstrates our continued ability to meet regulatory requirements as we continue to achieve milestones for all of our SmartMed software solutions."
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The ISO 13485 certification is the first step to ensure compliance with European MDR requirements. This certification complements the previous ISO 27001 and NEN 7510 certifications, which show that SmartMed meets all requirements around information security and carefully protects medical data. Alfred Godeke, CEO of SmartMed said, "SmartMed is committed to providing software that meets the highest quality standards in the industry as part of our efforts to provide maximum medication safety and value to our users. This certification is an important milestone and encourages our trajectory of continuous product improvement."
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The standard establishes requirements for an organization's quality management system and how it handles the design, development, production, installation and maintenance of medical devices. Companies that meet these quality requirements must prove that they consistently review and validate their product development and manufacturing processes, manage their operations with effective procedures, and maintain records for product traceability.
