Medical Device Suite
Medical Device Suite helps organizations manage ISO 14971 risk assessments, CEI 62366 usability engineering, and medical device design. It streamlines compliance, documentation, and regulatory tracking to ensure medical devices meet industry standards and accelerate approval timelines.
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Medical Device Suite Overview
Medical Device Suite is a specialized compliance and design management software tailored for the medical device industry. It helps organizations effectively manage ISO 14971 risk assessments, implement CEI 62366 usability engineering principles, and oversee the design and development of medical devices. By streamlining documentation, risk evaluation, usability analysis, and compliance tracking, the platform ensures that medical device developers meet regulatory standards efficiently. Whether for startups or established manufacturers, Medical Device Suite offers an intuitive, structured environment to align design processes with industry requirements, reduce errors, and accelerate regulatory approval timelines.
Features
ISO 14971 Risk Management Integration
IEC 62366 Usability Engineering Support
Integrated Design Control and Documentation
Audit-Ready Reporting and Compliance Tracking
Medical Device Suite Pricing Overview
Medical Device Suite Score
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FAQs
Medical Device Suite is a compliance software specifically tailored to meet the stringent regulatory requirements of the medical device industry, assisting in managing design controls, risk management, and documentation.
Yes, the platform helps manufacturers ensure that their products comply with international standards such as FDA, CE, and ISO.
Yes, it offers features to track and manage quality audits, corrective actions, and customer complaints, ensuring streamlined compliance processes.
Specific pricing details are not publicly disclosed; interested organizations should contact the vendor directly for customized pricing information.
While specific support details are not provided in the available information, organizations are advised to contact the vendor directly to inquire about support options and services.
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