Software Regulatory Services is a Life Science consulting firm that provides Information Tech nology, Regulatory Compliance and Risk Mana gement services to the Pharmaceutical, Bio- technology, and Medical Device industries.
Our company operates under very experiences leadership. With an average of more than 20 years of industry expertise, our associates are fully prepared to offer the rigth solution that your company demads.
ORLANDO CASTRO
Sr. Quality / Validation Engineer
Director
Orlando is an Electronic / Software Engineer with twenty years of experience in the pharmaceutical, medical device and diagnostics industry in both instruments and reagents manufacturing.
Orlando has led all facets of projects from conception, implementation, and validation. He also have a combined validation and production maintenance experience within the pharmaceutical and medical devices industry.
Orlando has equipment, utilities and facilities qualification experience including development and execution of protocols for Factory Acceptance Testing, Site Acceptance Testing, Installation Qualification, Operational Qualification, Computer System Validation, and Performance Qualification.
DINA CASTRO /
Sr. Engineer Reliability /Safety and Risk Management Specialist
Dina is an Electronic Engineer with twenty years of experience in the medical device industry.
She has vast experience performing Failure Modes and Effects Analysis (FMEA) of Medical Device manufacturer’s processes, including criticality analysis, to identify critical processes and process validation requirements.
Dina's strengths among others include managerial skills, solid technical background, and strong problem solving ability.
VICTOR GAMEZ
Sr. Medical device engineer
Victor Gamez is a medical device engineer expert in Class III devices development. Mr. Gamez has expertise in FDA and EU requirements for the commercialization of medical products, especially vascular devices (coronary stents, PTCA, peripheral balloons and stents, abdominal / thoracic aortic aneurysm stent-grafts).
Other areas of expertise include stent delivery system design, medical device manufacturing processes, and design / process excellence (six sigma) methodologies. Mr. Gamez is currently the lead engineer of the R&D mechanical group at Nipro Diabetes Systems, an insulin infusion pump developer and manufacturer, and has served as New Product Development Engineer for the Cardiology Division of Cordis / Johnson & Johnson and as Research and Development Engineer for the endovascular stent-grafts business of Medtronic, Inc.
