Al Pacheco
Certified Compliance Solutions, Inc.
al.pacheco@certifiedcompliance.com
SUMMARY
 Over 16 years in medical device product development
 Over 10 years as a technical manager responsible for hardware/software verification and
validation of medical devices
 Authored design control documentation and implemented full life-cycle design control
activities for over 50 medical device product releases
 Authored content for over ten 510(k) submission packages
 Established design history files for over 50 product releases and successfully presented
details of their compliance in over ten audits
 Authored a full range of operationally practical, FDA and ISO compliant quality systems
procedures and associated documentation templates
 International experience supporting outside US companies in establishing FDA compliance
for US product releases
 Five years experience instructing computer science classes at the junior college level
CONSULTING
Consultant to major companies in the medical device, diagnostics and diagnostic instrumentation
industries. Range of consulting services provided includes the authoring of 510(k) submission
packages, the authoring of risk management and technical design control documentation, the
authoring of FDA and ISO compliant quality systems procedures, ISO 13485, ISO 14971 and
IEC 62304 compliance audits and gap analysis reports, and guidance in implementing best
practices. Vertical markets supported include critical care and homecare ventilation, MRI image
processing applications, CT image processing applications, interventional radiological procedure
instrument guidance, IVD diagnostics and diagnostic instrumentation devices. Consulting style
integrates extensive technical and managerial product development experience with practical,
proven practices in establishing compliance with FDA and ISO regulations.
DESIGN AND VALIDATION EXPERIENCE
Over 30 years overall product development experience in a variety of technical and technical
management roles. Initial career experience in software engineering with specialization in the
development of test automation tools. Career advancements led to leadership roles establishing
standardized software development life-cycle processes and implementing formal independent
test engineering groups throughout those life-cycles. Career focus the last 16 years in product
development for Fortune 500 medical device companies. Primary responsibilities during this
period include all aspects of hardware/software verification and validation testing for complex
life support devices. These responsibilities included the establishment of quality systems
procedures and all associated design control documentation required to establish FDA
compliance. Track record of 100% positive outcome from FDA reviews and audits of design
control deliverables provided for over ten 510(k) submissions and design history files for over 50
new and enhancement product releases.
FDA SUBMISSIONS
Fluent in preparing 510(k) submissions and associated supporting documentation. Expert at
preparing submission packages that result in reduced review times and successful clearances .
Have provided 510(k) packages to the FDA for a wide range of medical devices from critical and
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Al Pacheco
Certified Compliance Solutions, Inc.
al.pacheco@certifiedcompliance.com
homecare ventilator products, orthopedic hardware/software systems, IVDs and interventional
radiology interventional instrument guidance devices..
AUDITOR
Expert at audits for compliance with FDA regulations and ISO standards. Audit style centers on
ensuring full organizational clarity of potential compliance exposures and providing practical
recommendations for addressing root cause. Audit feedback and recommendations based upon
practical career experience that resulted in successful outcomes from numerous FDA and third
party internal audits for life support devices that are held to extreme levels of compliance
scrutiny.
SOFTWARE DEVELOPMENT EXPERIENCE
Extensive experience in software development organizations with specialization in establishing
standard software development life-cycle processes and the integration of formal, independent
test groups into those cycles life-cycles. Product experience ranges from real-time imbedded
medical device software, clinical information systems, and a variety of specialized software
development areas ranging from operating systems, communications, and client-server
applications.
INSTRUCTOR
Hold lifetime California Junior College teaching credential and been an instructor for computer
science classes at the junior college level for five years. Have instructed courses in a variety of
programming languages and systems analysis and design.
EDUCATION
 MS/Systems Management, University of Southern California 1982
 BS/Information Systems, University of Arizona, 1979
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