Employees

Our employees are committed to help medical device, pharmaceutical and biotech companies achieve their goals by delivering high quality safe and effective products.

Corporate Team

Bill Kurani, CEO
MSEE (LSU), MSRA (SDSU), BC (Stanford)
Mr. Kurani and colleagues recognized the importance of product quality, safety and effectiveness for medical device and drugs early on. Kurani is RA/QA expert consultant with extensive experience in the regulatory affairs and quality assurance of medical device and drugs. Skilled in securing international (EU), federal (FDA), state, and local regulatory marketing approvals for medical device and drugs. Excellent background in product design, development, testing, process validation and launch. Performed risk analysis on every aspect of the medical device and drugs manufacturing process before approval and launch helping companies deliver robust products. Helped launch 27+ successfully commercial products.

Education/Certifications: MSEE (LSU), MSRA (SDSU), BC (Stanford). Bill holds Masters of Science in Electrical Engineering (MSEE) from Louisiana State University, Master of Science in Regulatory Affairs (MSRA) from San Diego State University and Bioinformatics Certificate (BC) from Stanford University. Certified ISO 13485 Auditor.

Management: During his 22 year career in domestic and international management of engineers and scientists he has engaged in various senior, principal and management roles in engineering, quality assurance, and regulatory affairs in several firms in the area of medical device, medicines and information technology arenas. He has also worked hands on in information technology industry automating several core infrastructure projects.

Commercial Products: Kurani has been part of 27+ successfully launched commercial products providing quality oversight and regulatory guidance in the area of EKG, ECG, whole blood analyzer, gene chip expression, drug metabolism, genotyping, chromosome copy number analysis instrumentation system. He has years of experience in regulatory submission and approvals of both Medical Device and Medicinal products and implementing electronic quality management system and document control system.

Papers, Publications: He is author of books Applied UNIX Programming - Volume 1 & 2 published by Prentice Hall and has written a thesis on Electronic Regulatory Submissions and Review For Drugs and Medical Devices presented to the Faculty of San Diego State University He has delivered more than 36 papers and seminars to a wide variety of audiences and locales in areas of science, quality assurance, and regulatory issues, and has various trade journal, proceedings, and symposia publications.

Auditing: He has performed many 1st, 2nd and third party audits of medical device firms and suppliers.

Professional Activities: Bill is active member of the American Society for Quality (ASQ), Regulatory Affairs Professional Society (RAPS), Institute of Electrical Engineers (IEEE) and Gemological Institute of America (GIA) Alumni.

Teaching: Currently teaches five classes in the area of Regulatory Electronic Submission, Validation, Nonconforming Material, Deviations and Corrective Action and Preventive Action. Previous to this conducted numerous classes in the area of medical device instrumentation validation.

Honors: Author of two books, several articles in RAPS Focus magazine and have consistently received far exceeds expectations award in the companies.

Clients

Affymetrix, Abbott Diagnostics, Ligand Pharmaceuticals, Sun Microsystems, Motorola, Star Sight Telecast, Vicor Systems, Antrix, Ehealthworld, Epoolandspa, Flexwatch, Unisoft, Nicolet Medical Instruments.