Menlo Park Associates
  • Menlo Park Associates
  • Blog
  • About
  • Menlo Park Associates
  • Blog
  • About
Search by typing & pressing enter

YOUR CART

The FDA Recall Epidemic is not over.

How can your company take chances on future FDA recalls when a method exists that tells you how to reduce their probabilities in a straightforward manner?

Drop risks by what you need.

Reduce them iteratively and incrementally until residual risks are acceptable and outweighed by benefits.
FDA medical device recalls
were down 22% in FY2019.

Picture
That’s good. Just don't open the champagne yet. Device introductions dropped 15% as well. And, correlation with recalls has held at about 96% begining in FY2003. Those changes in recalls come from basic economics, not poor risk management. And not from the Wuhan CVD-19 virus. That came in FY2020.

Recalls fell again in FY2019. But, their 96% cor­relation kept pace with new devices on the market. Don't resign to this fate.

Every device manufactur­ed is another opportunity for faults and recalls at these same rates.

5 WAYS TO STOP FDA RECALLS
  1. Detectability to the Rescue
  2. Knowledge Synergy
  3. Sharing Synergy
  4. Precise Probabilities
  5. Anchoring Standards

The method is free. And, so is remote consulting help, for the first 100 that interview, with the implementation while this terrible COVID-19 pandemic  is upon us.
    Give your email address and recieve the PDF file of the white-paper. No SPAM.
    Click the button to request your white-paper on 5 Ways to Stop FDA Recalls.
CLICK to request 5 Ways to Stop FDA Recalls
Picture
See how Menlo Park Project™ by Menlo Park Software™ helps the Menlo Park Associates™ 5 Ways Risk Management Method
  • Stores, tracks and enforces, (turns red and generates reminder messages), 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).
  • Captures and documents all team-member collaboration related to risk analysis and safety-related procedures.
Picture

Click for the FDA regulatory 'Compliance Crisis' cure.

Medical device company investors: what is your vision for the industry?


What's in Your History Files? ™

Richard L. Bollinger
618 Fifth Street
Ann Arbor, MI 48103

+1 734-662-7752
USA 888-828-8107
rick@menloparkassociates.com
TOKENS LEFT

All rights reserved © 2020 Menlo Park Associates LLC. 
Owner of Menlo Park Software LLC, Member of MichBio.

Powered by Create your own unique website with customizable templates.