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
• FDA Submittal process – lack of knowledge (V&V differences)
• Test plan is incomplete, doesn’t include (out of the box) scenario testing
  • Unexpected User Actions
  • Abnormal System Behavior

*Note: majority of unexpected, critical defects discovered/mitigated here

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 Us Today – request a Free Recall Prevention Assessment!