Selected Achievements

More than 50 US FDA 510(k) Clearances
Eight US FDA PMA approvals
CE Mark for self-declared and self-test products (>100)
Global product registrations in EU, Canada, China, Japan, Australia, Middle East, South and Latin America (>100)
Successful FDA pre-submission applications to foster efficient product approval/clearance
Effective use of "Breakthrough Designation" and "Emergency Use" for novel products, including COVID RNA Diagnostics
Global transition of product registration to new corporate ownership

Currently installing QMS at two diagnostic start-up companies
Develop and Install new QMS at PTS and Accriva Diagnostics.
Integrate the QMS of three independent companies to create a single QMS for Siemens Medical Diagnostics.
Developed compliant QMS training programs and installed for clients
Develop a Comprehensive Quality Improvement Plan (CQIP) for compliance remediation and QMS transition to resolve a company's FDA Warning Letter
More than 50 successful FDA and ISO 13485 audits without major findings

Resolved FDA Warning Letter in 15 months for client using CQIP
Successful management of product recalls and field corrections
Installed compliant complaint handling and resolution
Installed compliant programs for CAPA, non-conformance, design control, validation and training
Developed and implemented post market surveillance programs for USA and EU
Negotiated reimbursement for novel diagnostic tests thru US - CMS (Medicare & Medicaid)

Currently serve as consultant CSO and CTO to two entrepreneurial start-up IVD companies
Ten issued patents for diagnostics
Development of more than 40 novel diagnostic products; 97% successfully commercialized
Co-authored patent for COVID-19 SARS CoV 2 POCT Dx Assay
Provide Expert Witness Support in IP challenges and defense
Redesign of existing products for optimized performance to meet current standards
Design and execution of clinical trials for product approval and demonstration of clinical utility

Currently serve as Scientific Advisor and Board of Director on three medical device companies
CSO of Accriva Diagnostics leading to sale (2017; at 4 times revenue)
CSO of PTS leading to sale (2015; at 2.5 times revenue)
Compliance/Regulatory Due Diligence Leader for merger of Bayer, DPC and Dade Behring to Siemens Diagnostics (2007)
Successfully relocate ITC business from NJ to CA; merge with Accumetrics to form Accriva (2013)
Primary executive contact and adviser to Board of Directors (PTS, ITC, Accriva)

Served as Chair of AACC CPOCT Division and Chair of CLSI POCT Area Committee
Served on National (CLSI) and International Standards (ISO) Development Committees to author standards
Invited presenter at FDA & NIH Workshops and Training Programs
Authored and co-authored more than
- 100 scientific abstracts
- 30 peer reviewed publications
- 65 scientific symposia
- Corporate "White Papers"