Risk ID (Recall Prevention) Program

We help you deliver Med Tech systems your customers can trust.

“Kris utilized the Risk Reduction Process successfully on a project which married numerous medical devices to a hospital system for the first time – with feature changes to all aspects of the system, and it’s been running flawlessly for several years now.”

Marketing Manager – Fortune 100 Medical Device Manufacturer

We help our clients identify the high-risk areas in their code, reveal and mitigate hidden critical defects, and deliver reliable high performing devices on a routine basis.

Benefits 

  • Measurably improved reliability and scalability
  • Enhanced patient safety and customer confidence
  • Increased confidence with new feature/product releases
  • Early critical defect detection prevents escalating cost and impact on deliverables
    • Contributes directly to recall prevention
  • Improved user experience and customer satisfaction with your products

Recall Prevention for Biotech (Medical Device) Systems

Challenges

High severity defects escape to production -> recalls / stop ship / FDA audits

  • R&D/QA teams’ inability to identify all high risk areas of the code and system
  • Cyber Security vulnerabilities with Medical Devices
  • Test plan is incomplete, doesn’t include targeted negative testing
  • FDA Submittal process – lack of knowledge (V&V differences)

Project delays, slipped dates, inability to accurately forecast timelines

  • Lack of understanding – what “not” to test
  • Critical defects discovered late in project or post release

Unexpected system performance issues

  • Nonexistent or incomplete performance test plan
  • Inexperienced load/stress testing team

Solution – Predictable Release Schedules and Increased Confidence

Identification of High Risk areas

  • Improve system reliability
  • Reduce test cycle times
  • Cut costly rework
  • Proper identification/remediation of Cyber Security vulnerabilities
  • Accurate, acceptable FDA submittal’s

Implement repeatable processes

  • Predictable schedules
  • Improve user experience
  • Training: FDA Audit Processes and Approaches
    • Inspection program put in place
    • Successfully complete inspections/audits
  • 30 years MedTech Experience – applied to your team
    • Increase Patient Safety
    • Recall reduction
    • Minimize stop ship occurrences

How does the recall prevention program work?

One – identify all high risk areas within the application, device and system

{if a new App: identify critical path, all ‘must work’ user and connected system work flows within the application, device or system}

{if existing App: identify all potentially impacted functionality affected by changes}

 

Two – using inductive logic, create ‘what if’ scenarios for all critical path and potentially impacted functionality

Three – convert all ‘what if’ scenarios into targeted negative test cases (for R&D/QA teams)

Four – prioritize all targeted negative test cases utilizing probability versus impact process

Five – feed high impact scenarios/targeted negative test cases directly into R&D and QA Plans

Six – keep entire project team tightly focused on high risk plans and tasks until release

Seven – update process documentation for ongoing team training & process improvement

 

Contact Judy Cirilos today – ask her to schedule a free Recall Prevention Assessment!

judy.cirilos@advantu.com

858.275.2106

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