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AESC has combined its extensive risk and safety experience with monitor and control based quality assurance programs to perform preproduction assessment that focuses on the medical equipment manufacturing sector. The need for this service has grown from Food and Drug Administrations requirement for medical device manufacturers to have PQA programs (see references), and the synergy that exists in the methodology for risk reduction from accidents in general. The underlying methodology that applies to product failure risk reduction, also applies to and is compatible with FDA regulatory documents.

Safety devices typically require a "Safety Integrity Level" (SIL) determination. We provide this as part of safety risk assessment. Most widely accepted guidelines related to SIL determination are IEC 61508, and ISA S84.

The following section is an abstract about applicability of PRA & PRAM methodology to medical devices:

In the specification phase of a PQA program, in addition to desired performance characteristics, specifications should include safety, and reliability characteristics. As part of design review for a PQA program, specification changes during R&D should be assessed to ensure that safety specifications are not compromised.

As part of design review for a PQA program, identification of design weakness phase includes FMECA, and or FTA analysis to reveal any potential design weaknesses. FTA is very applicable to medical devices since man-machine interfaces could be modeled to prove or disprove adverse effects on users. In both FMECA and FTA human-induced hazardous situations should be assessed.

As part of design review for a PQA program, reliability assessment is highly recommended since post production costs of retrofitting, retraining, liabilities, recalls, and customer loyalty, outweigh preproduction assessment and corrections.

In the preproduction phase, part and material selection should be in accordance with the reliability specification. Parts with proven reliability are recommended, as well as iteration through system reliability models with each part's specification entered in the models, to ensure overall system reliability goals are achieved.

In addition to software quality assurance plans that are part of the development cycle, considerations should be given to security and human interface aspects of the software system with respect to potential sources of risk.

Labeling, documentation and communication are typically considered as part of the design process, however we recommend assessment of these elements and their potential contribution to failures.

FDA - CDRH - A Prespective on Medical Device Risk Management
William Midgette
Heart Rhythm Society
Washington, D.C.
Date: 16 September 2005
Size:  77K
Design Control Inspection Results

FDA. "Preproduction quality assurance planning: Recommendations for medical device manufacturers." The Food and Drug Administration, Center for Devices and Radiological Health, Rockville , MD, September 1989.

FDA. "Guideline on general principles of process validation." The Food and Drug Administration, Center for Drugs and Biologies and Center for Devices and Radiological Health, Rockville, MD, May 1987.
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