HCRQ
System Safety, Software Safety Experts
Since 1986
"The Key To A Safer World"
salus populi suprema lex




Medical Device Safety


One Of Our Medical Device Safety Contracts

 Our Client - The Target Of A $20 Million Law Suit


This client was the target of multiple law suits.

The first was for $20 million.

The reason - patient deaths.

The cause - software.

The solution - bring us on board.

Another One Of Our Medical Device Safety Contracts

 Baxter Diagnostics' Immunoassay System Safety Analysis


Analyzed hazards included false-positive and false-negative diagnoses.

EDS commended our work -
"Excellent service, responsiveness and extreme attention to detail.
We were quite impressed and had them take over the project completely.
The project was completed on time and, above all, our customer was very pleased."

Another One Of Our Medical Device Safety Contracts

 Aastrom Cell Production System Safety Analyses


The Aastrom CPS is an integrated system of instrumentation and single-use consumable kits that implements Aastrom's patented "single-pass perfusion" process in a fully automated, closed fluid path culturing system to optimize cell growth and viability.

This proprietary system provides nutrients to cells by mimicking the natural cell-growth environment, and enabling human cells to grow while retaining high biological function. In addition, this system provides GMP-compliant manufacturing and automated process control for the commercial-scale production of cells to be used in medical practice.

We performed FMEAs, software hazard analyses, fault tree analysis, and verification cross-reference matrix on the CPS incubator, processor and system manager.

Do you need help with:

  • Medical Devices - Application of Risk Management to Medical Devices - ISO 14971:2000, ISO, December 2000,
  • Medical Devices - Application of Risk Management to Medical Devices, Rationale for Requirements - ISO 14971:2000/Amd 1:2003, ISO, 2003,
  • Medical Electrical Equipment - Part 1-4: General Requirements For Safety - Collateral Standard: Programmable Electrical Medical Systems - IEC 60601-1-4, International Electrotechnical Commission, Geneva, Switzerland, April 7, 2000,
  • Guidance For The Content Of Premarket Submissions For Software Contained In Medical Devices, Food and Drug Administration, May 11, 2005,
  • General Principles Of Software Validation - Final Guidance For Industry And FDA Staff, Food and Drug Administration, January 11, 2002, or
  • Guidance For Industry, FDA Reviewers And Compliance On Off-The-Shelf Software Use In Medical Devices, Food and Drug Administration, September 9, 1999.

Perhaps you are going to require assistance with:

  • Medical Device Software - Software Life-Cycle Processes - IEC 62304





If you are less fortunate, you may need our help in other ways.

THERAC-25

Do you remember those horrible accidents in '86 and '87?

Does MALFUNCTION 54 sound familiar?

We came to the rescue of the manufacturer by performing extensive analysis
of the software.

Despite all of the articles that have been written, aside from the manufacturer,
we know more about the safety of this device than anyone.

Take a look at our expertise in post-accident safety analysis.



My name is Robert Del Rio. Contact me if you need help with medical device safety.