Medical Devices

Optimize the Product Development Processes, Compliance and Quality


The pressure on Medical Device Companies to bring more products to market faster is not easy to handle due to the very regulated nature of the industry. The exact nature of the regulations have resulted in many medical Device companies adopting way of working that are not efficient but these have been accepted due to fear of the regulatory legislations.

 

Now Medical Device companies are faced with critical needs to change their ways of working and adopt more seamless processes across the departmental boundaries combined with stopping the psychical paper trail and/or harmonizing the islands of information that exits.

 

Aras is designed to support the cross departmental processes in bringing a new product to market, changing existing once or anything other process that exist within the products lifecycle.


Capabilities in Aras Innovator for Medical Device Companies include:

  • Process support to optimize Global Product Development, including Design History Files (DHF) and Device Master Records (DMR), Audit Compliance, Corrective Actions, Enterprise Change Management, and Verification and Validation
  • Functionality to support Standards, Quality and Regulatory Compliance, including CAPA, 21 CFR Part 820 Quality System Regulation, 21 CFR Part 11 Compliance, ISO 13485, the European MDD (2007/47/EC) and Support for Level 1 ,2 & 3 Devices
  • Performance management to improve Reporting, KPIs, Dashboards and Scorecards
  • A Security and traceability model designed for supporting the global collaborative requirements
  • High user acceptance through an easy to use Intuitive Microsoft Look and Feel Web based interface

 

Solutions for the Medical Device companies have been developed with and for companies in the industry, for details please contact Minerva.


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