Medical Services

Aras Innovator® enterprise software solutions help Medical Device companies reduce product risks, manage compliance to quality systems and environmental regulations, and achieve Lean product development.

FMEA & APQP functionality streamlines compliance to FDA QSR regulations and supports the development of quality products to mitigate potential product risks. RoHS & WEEE functionality ensures environmental compliance to the coming international regulatory requirements.

Lean Product Development is achieved with Aras solutions. Visual management program status dashboards provide the ability to drill down and take action.

Industry Challenges
Medical industry conditions are forcing unprecedented pressure on profits due to a combination of issues:
• Need to reduce risk of critical quality, health, and safety issues
• 21 CFR Part 820 Quality System Regulation
• 21 CFR Part 11 compliance
• Environmental compliance regulations coming
• Global product development coordination for supply chain readiness

Key Features

FMEA Risk Management
• FMEAs manage potential new product risks during product development

CAPA Compliance
• Online CAPA forms & workflows streamline closed-loop compliance

Environmental Compliance
• Ensure compliance across future regulations including Chinaand the EU

Online Collaboration
• Web-based online collaboration for global coordination

Adaptive Standardisation
• Adapt processes quickly to support new regulatory requirements and standards