We help you release Med Tech systems your customers (and the FDA) will love…

Don Canal, Senior Management, Clarify Medical “Lina did a great job for us. Kris was great as well – very flexible and responsive to any issues. Great work and a great team to work with!”

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.

Click these links to learn how we help teams overcome the following challenges:

Recall Prevention for Biotech (Medical Device) Systems
System Performance
Test Automation

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}

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 risk 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

Benefits

Significantly reduced Time To Market
Measurably improved reliability and scalability
Increased profits and revenue via best in class processes
Predictable forecast accuracy and delivery dates
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

System Performance

The Advantu team has spent years developing a methodical approach to tracking down and mitigating system performance issues. This methodology has been successfully applied to a number of systems in industries as disparate as cyber-security, agriculture and software as a service, as well as regulated industries such as medical devices.

By employing our extensive expertise gained through years of development and test experience – Advantu will help drive your project to completion, with dependable reliability and world class user experience.

We are your committed partner in resolving issues such as these:

Issues

Unacceptable user experience
Unreliable long term ‘up time’
Missing or corrupted data
Browser interface painfully slow
Reports take forever to load and display
Search feature / Print requests – take forever or time out
Multiple users cause serious degradation, freeze or system crash
System Navigation is so slow; you forget what you were doing

Solution – Quantifiable Performance

System Analysis & Remediation

We will identify all the bottlenecks and system design shortcomings
Review findings with your team
Provide recommendations for remediation
Collaboratively determine the best action plan
Work with your team to implement corrective steps
Fully test the system against updated behavioral expectations
Ensure speed, capacity, data integrity and reliability exceed customer demands
Improve customer satisfaction with your products

Test Automation