Medical Devices Solutions - Aras Corporation

Aras for Medical Device Companies

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 Device companies are facing new product complexities that can have a catastrophic impact on revenues and profits:

Need to reduce risk of critical quality, health, and saftey 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

Aras Innovator enterprise solutions integrate quality & environmental compliance and Lean product development to achieve compliance.

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 China and the EU

Online Collaboration

Web-based online collaboration for global project coordination

Adaptive Standardization

Adapt processes quickly to support new regulatory requirements and standards

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