Quality as it should be.
The leading quality management software solution for medical product companies.
Fast. Efficient. Streamlined. Compliant.
Design Control
Manage and track design projects through the lifecycle phases. Define and manage deliverables by phase.
Document Control
Submit, route, review/approve and implement electronic document changes and deviations.
Training Management
Define and manage training requirements. Mark training complete. Authorize read and understand training.
Audit Management
Manage internal, supplier, and external audits. Record findings, observations, and resolutions.
CAPA
Manage corrective, preventive and continuous improvement requests. Track detailed root-cause analysis and action plans.
Equipment Management
Manage calibration, maintenance and qualification activities, and unplanned events.
Nonconforming Materials
Review/approve proposed dispositions via the NCM Review Board (MRB).
Complaint Handling
Capture, track and manage product or service issues. Prioritize, investigate, report, trend complaints.
Authentication Management
Grand Avenue’s Authentication Management provides support for single sign-on (SSO) authentication within Grand Avenue.
Training Assessment
Extends the Training Management module to use tests/quizzes to assess a user’s understanding of the completed training.
Risk Management
Identify hazards and harms associated with the medical device. Estimate, evaluate, mitigate, and control associated risks.
Quality as it should be
The leading quality management software solution for medical product companies.
Fast. Efficient. Streamlined. Compliant.
Design Control
Manage and track design projects through the lifecycle phases. Define and manage deliverables by phase.
Document Control
Submit, route, review/approve and implement electronic document changes and deviations.
Training Management
Define and manage training requirements. Mark training complete. Authorize read and understand training.
Audit Management
Manage internal, supplier, and external audits. Record findings, observations, and resolutions.
CAPA
Manage corrective, preventive and continuous improvement requests. Track detailed root-cause analysis and action plans.
Equipment Management
Manage calibration, maintenance and qualification activities, and unplanned events.
Nonconforming Materials
Review/approve proposed dispositions via the NCM Review Board (MRB).
Complaint Handling
Capture, track and manage product or service issues. Prioritize, investigate, report, trend complaints.
Authentication Management
Grand Avenue’s Authentication Management provides support for single sign-on (SSO) authentication within Grand Avenue.
Training Assessment
Extends the Training Management module to use tests/quizzes to assess a user’s understanding of the completed training.
Risk Management
Identify hazards and harms associated with the medical device. Estimate, evaluate, mitigate, and control associated risks.
Trusted by the Leading MedTech Innovators
Grand Avenue – helping medical product innovators turn their vision into reality.
Our greatest privilege is helping med-tech innovators and leaders turn their ideas, visions and dreams into reality. We solve the quality compliance puzzle so innovators can focus on products, treatments, therapies, procedures, and devices that make people’s lives better.
Compliance through Grand Avenue’s SaaS solution – shortening your time to results.
Grand Avenue provides what you need for quality compliance. A modular solution – start small and expand as you grow. Leading edge software and hosting technology – always on, whenever you need it, wherever you need it. Best practices – for streamlined compliance.
“Grand Avenue Software (GAS) is intuitive, easy to use, effective and has been found fully compliant to FDA and ISO 13485 requirements in all of our internal and external audits from regulatory bodies.”
Amed Ayubi
Corvent Medical
Amed Ayubi
Corvent Medical