Medical Device Equipment Experience
	Food and Drug Administration
	Requirement: Update PMA, 510(k), and cGMP requirements to include software validation considerations.
	Solution: Trained FDA staff in systems and software safety standards and validation processes.
	Benefit: Practical understanding of compliance issues.
	Medical Manufacturers of Computer-Controlled Equipment
	Requirement: Apply updated requirements for validation of computer-controlled equipment.
	Solution: Trained regulatory affairs professionals in systems safety standards and validation processes.
	Benefit:  Approximately thirty percent reduction in costs of compliance.
	Medical Manufacturer of Contact Lenses
	Requirement: Apply updated requirements for validation of computer-controlled equipment used in contact lens manufacture, sterilization, and packaging.
	Solution: Trained engineering and production staff in systems and software safety standards.  Advised on validation processes for vendor-supplied equipment.
	Benefit:  Clarified compliance issues associated with contact lens regulations.
	Medical Manufacturer of Biologics Test Equipment
	Requirement: Apply current requirements for validation of instrumentation for biologics testing.
	Solution: Conducted independent verification and validation for 510(k) submission.
	Benefit: Trained engineers in software quality assurance methods.
	Underwriters Laboratories, Inc.
	Requirement: Develop standards and review processes for safety of products having integrated software controls.
	Solution: Led the development of the Standard for Safety:  UL 1998 and established a corresponding review process.
	Benefit: A standard for software that is recognized by ANSI and the FDA for complying with product safety regulations. .