Medical Device

Accountable care and value-based reimbursement are causing a significant shift in the medical device industry. Value of the device and data capability alone will not drive sales. Health care practitioners are looking for solutions that bundle device, data, and real-time analytics together in their health care systems. These device solutions need to be capable of having improved decision-making outcomes and actionable tracking of data into existing electronic medical record systems and health information exchanges. These devices also need to provide the efficacy and results data required in value-based reimbursement models. In today’s medical environment, nearly all manufacturers of medical devices face two key interrelated challenges the first being, how to adapt to the shift to value-based payment models and secondly, how to protect margins with products that use strategic interoperability platforms to create solutions with integration, data aggregation, and analytics capabilities.

The Sharrix risk management solution has out of the box DFMEA, PFMEA and Control Plan models that provide comprehensive risk assessment tools to promote best practices and utilise valuable lessons learned data that can be used in your new medical device designs and production operations. We help medical device companies identify, analyze, and mitigate operational risk within one plate form that allows timely closed loop, workflow driven, action tracking on any mobile device no matter where the action assignees are geographically located.

Sharrix provides Operational Risk Management solutions that empower you with a comprehensive view of your risk management priorities and help to create corporate best practices and provide a way to share lessons learned across your operations. Sharrix helps simplify Quality Risk Management activities by providing:

• A consistent corporate standard for all risk management processes, ensuring that risks are identified, measured and mitigated in similar ways with shared best practices;
• Audit trails to ensure compliance with regional and adopted regulations;
• The ability to predict and prevent issues from occurring by uncovering leading and lagging indicators and understanding patterns of risk;
• A continuous improvement approach to risk management, integrating risk studies with mobile capable Action Tracking;
• The ability to transform risk management data into key decision making criteria;
• Corporate visibility of risks, aggregate risks, risk management adoption and regulatory compliance across regions, business units, and sites.