Implantable Devices with Matrix Requirements®
Implantable device products must meet the highest standards of biocompatibility, safety, and performance. Matrix Requirements® delivers the end-to-end support needed to navigate these demanding lifecycles.
Implantable Devices are at the heart of Matrix Requirements
Implantable Devices represent some of the most complex and highly regulated technologies in healthcare, often operating in critical, long-term roles within the human body. Whether electronic systems like pacemakers and neurostimulators or mechanical implants such as artificial joints, these products must meet the highest standards of biocompatibility, safety, and performance. Matrix Requirements® delivers the end-to-end support needed to navigate these demanding lifecycles, ensuring regulatory alignment and quality assurance from initial design through post-market activities:
Long-Term Risk and Safety Management Support: Comprehensively document and manage risk in accordance with ISO 14971 and relevant device-specific standards (ISO 14708, ISO 5840…).
Biocompatibility and Material Traceability: Maintain full traceability of materials, coatings, and sterilization processes to support biocompatibility and implant safety.
Complex System Engineering: Coordinate interdisciplinary development across electronics, software, mechanical design, and clinical validation in a unified environment.
Post-Market Surveillance Integration: Easily extend traceability into post-market feedback and vigilance reporting to support ongoing compliance and lifecycle improvements with the eQMS module.
Hear from our customers
Matrix Requirements is super effective at handling the complex relationships between design objects, and its user-friendliness convinced us that we’d found the perfect fit for our quality and requirements management needs.”
Michael Strelow, Quality Manager, ViViRA
