The FDA Compliance Crisis

See the flat black line on the chart?

That flat BLACK LINE on the chart in the picture above shows the problem. It displays the percentage of inspection outcomes with voluntary or official actions required.

The percentage of FDA inspections with actions has been stuck between 30% to 40% for a decade.

Click the chart to expand it.

Rick Bollinger, CEO and Founder of Menlo Park Associates, is a management consultant with decades of project management experience. Recognizing and solving process problems was his day job for many of those years.

He managed projects in both medical device and pharmaceutical manufacturing. His travel, work, and experience allowed him to design and build his prototype project management platform.

This horrible trend became evident while researching another medical device industry problem (the "Recall Epidemic"). We can call this bad news the "FDA Compliance Crisis".

That's your "FDA Compliance Crisis".

So, why haven't QMS software vendors solved this for you?

After all, wouldn't you rather be stuck between 0% and 10%?

The solution is software. But, not more of the same old QMS software that used to run on Modular Mainframe computers.
And, certainly not more outsourcing.

The FDA Compliance Solution is 21st Century QMS and Collaboration software for Safety-Critical projects.

Click above to Interview and get a DEMO.
By appointment only.

If you can only spare a half hour, only take the internet survey. Same questions. No demo. Just click the servey button below or the cross just above.

Menlo Park Project QMS/Collaboration Software

Already a core prototype has been developed. We just need to add some QMS features to accept, store and track procedures. Give it your best shot. See a DEMO before committing to anything.

The hardest part is done. The core platform already tracks work with alerts and reports. We can design the few missing parts to meet your exact needs. You'll want a DEMO before deciding.

Solutions of this scale need the help of medical device industry experts like you. An hour of your time is needed. That's very valuable. Grab your time slot. The number are limited.

Let's fix this problem once and for all.

See what's coming for the medical device industry.
Just click here to peek at THE FUTURE and mold its features to match your precise purposes.

It would be helpful to interview you.

Imagine the power of your industry experience, and that of your peers', in interviews. And, in seeing demonstrations using Zoom, or whatever.

Together, we can complete a better design, deliver better software, and make a better future.

Improves inspections and citations.
Improves project performance.
Improves risk management.

HOW TO IMPROVE INSPECTIONS AND CITATIONS

Reduce Form 483's, CAPAs, Non-Conformances, Device Reports and Complaints.

Eliminate errors of omission and commission.

Capture collaboration content as evidence of risk management and FDA regulatory compliance.

Eliminate Errors

In the core system prototype, issues, risks and tasks turn RED when overdue in dialogs, meetings and reports. And YELLOW when nearly due. This eliminates errors of omission.

The core system now also allows interested team members and stakeholders to subcribe to alerts and reminders of status and progress. Resulting follow up and review eliminates errors of commission that can spoil FDA compliance.

Fix FDA Regulatory Compliance

QMS and regular SOP procedures will be stored by the new software and dropped into projects to define work for team members. Procedures will be used in all stages of device manufacture. Everybody gets to look good. Especially you.

Execution related to issues, tasks, and risks is now tracked and enforced. They show up in alerts, status reports, meeting agendas and minutes. All of that is now generated automatically, including collaboration content, for history records and files to provide evidence of FDA regulatory compliance. This existing feature is now PATENT PENDING.

HOW TO IMPROVE PROJECT PERFORMANCE

Alert stakeholders to issue, risk and task status changes and reminders. Save time by generating status reports and meeting agenda and minutes documents instead of creating them manually. These serve as traditional operational documents, as well as evidence of FDA regulatory compliance. Already implemented in core system prototype.

Use the new project management platform to organize work issues, tasks and risks. The resulting structure could then be used to collaborate at appropriate levels and locations. Lastly, generate status reports and meeting documents to capture collaboration content as part of regulatory evidence without outsourcing or manual creation. Already implemented in core system prototype.

HOW TO IMPROVE RISK MANAGEMENT

Define issues, tasks, risks, faults, failure modes and procedures for management in the platform. Use them to keep track of risk parameters. Facilitate Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA).

Use issues, tasks, risks, faults, amd failure modes in meeting agendas to organize their content to bring the right people together and follow a method that iteratively and incrementally reduces risk probabilities. Request your copy of the the method below. Or, see more about the RECALL EPIDEMIC.

Interview
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See how Menlo Park Project™ by Menlo Park Software helps the
Menlo Park Associates Risk Management Method

Stores, tracks and enforces execution related to procedures, issues, tasks, risks, faults and failure modes.
Manages and documents the parameters and calculations of Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA) and Benefit-Risk Assessment (BRA).
Capture and document all team-member collaboration related to risk management and safety-related procedures.

The Recall Epidemic

Menlo Park Project™ will be released so you and peers will improve inspections, performance and risk management.

Click for the FDA 'Recall Epidemic' cure.
Medical device company investors: what is your vision for the industry?

In 2017 the Owner read an article: "What's Behind the Recall Epidemic?" The authors identified a real problem. But, their criticism of the entire medical device industry was wrong. You can request a white-paper on the correct solution below. It's titled 5 Ways to Stop FDA Recalls. A method is described that will find and mitigate more failure modes and lower the probabilty of FDA recalls. And, it's FREE. Just request the PDF.

Ask about Digital SOP's.