Ashkon R. Email & Phone Number

Costa Mesa, California, United States

Founder of Medical Device QMS consulting firm. Expertise in SaMD/SiMD and focus on AI.

San Francisco Bay Area

Recognized by Fast Company as 2022 Most Innovative Companies leading a new category of clinical-grade, safe and effective drug-free mental health programs available through CVS Health (Caremark), Evernorth (Express Scripts/Cigna), NHS Scotland. Owned the QMS designed to sell multiple digital therapeutics in the US/UK/EU markets- Led growth of the QMS team to support the business objectives- Led expansion of the QMS to ensure compliance with FDA 21 CFR regulations as well the following standards: ISO 13485:2016, ISO 14971:2019, ISO 62304:2016, ISO 14155:2020, IEC 62366-1:2015/Amd 1:2020- Led the company through successful ISO 13485 and EU MDR surveillance and recertifications- Led the QMS transition out of FDA's Public Health Emergency- Led the QMS integration post-acquisition of Limbix- Supported DTAC certification of the Digital Health products in the UK- Supported Clinical Investigations of the products- Implemented the least burdensome principle to promote efficiency in the particular areas of labeling and design controls

San Jose, California, United States

- Externally-facing role in the professional services organization. Delivering regulated SaMD (Software-as-a-Medical-Device) products for leading pharmaceutical clients- Responsible for product definition and ensuring delivery to scope and timelines- Own client interaction, grooming, release planning, sprint management, scrum ceremonies- Led large development teams to launching and supporting regulated products

South San Francisco, United States

- Develop the software quality management system in compliance with ISO 14971, ISO 13485, ISO 62366, IEC 62304 and 21 CFR Part 820 and 21 CFR Part 11- Project support to ensure compliance to the quality system around risk management, design controls, software development lifecycle (SDLC) and post-market surveillance (PMS). Author risk management deliverables- Lead the automation tooling and process optimization projects- Representation on the FDA Pre-Cert Pilot Program

Campbell, Ca

- Led Development of the Software Quality System to the point of compliance with IEC 62304:2006+A1:2015, and the various FDA Guidances- Authored and reviewed the software quality deliverables for development of a multi-piece platform of embedded, mobile (Android), and web software applications (C++, Javascript)- Assisted with the system engineering activities of design and requirements elicitationSpearheaded improvement efforts on Software Development LifeCycle, Configuration Management, and Problem Report Resolution processes- Responsible for risk management activities including SOUP and Software Hazard Analysis, and FMEAs

Irvine Ca

- Led SW Quality for a multi-piece embedded system of class B and class C software (C++, C#)Responsible for NPD (New Product Development) SWQA activities from concept through Design Transfer- Responsible for risk management activities including Software Hazard Analysis and Cybersecurity - Designed and oversaw the implementation of the software defect management lifecycle- Established a new automated software testing frame increasing efficiency and test quality (RoBoT, Python)

Irvine, Ca

- Led SW Quality for a sustaining project that resulted in 33% cost savings per unit- Re-designed the test suite architecture on a legacy product to improve efficiency by 25%- Prepared and released quality documents such as RTM, Testing Summary and Known Issues Reports

Irvine

Irvine, Ca

Breathe technologies designs and manufactures non-invasive open ventilation (NIOV) devices for patients with chronic obstructive pulmonary disorder (COPD), as well as continuous positive airway pressure (CPAP) devices for treatment of sleep-related breathing disorders. Responsibilities:Design and Development of Detection Algorithms (MATLAB)Development of a Simulated Algorithm Evaluation Environment (C / MATLAB Integration by MEX) Embedded Systems Programming (ARM F2/C3 Processor, Green Hill / AVR Compiler)Development of PC/Embedded Communication Software (C++ / C)Clinical Trial Setup and Data collection (European Data Format)Design and Development of an Object-Oriented Library for Clinical Data Analysis (MATLAB)Pressure Waveform Testing for PID Controller TuningDevelopment of Automated Data Analysis and Report Generation Software (MATLAB)V&V Documentation for the 510k Submission (Protocols, Reports, Design Documents)

Irvine, Ca

ev3 neurovascular designs and manufactures various products including Micro Catheters, Guidewires, Retrieval Devices, Stents, Coils, and Liquid Embolics. Responsibilities:Correspondence with the FDA, Notified Bodies and other International ConsultantsRoutine Regulatory Submissions (PMA Annual Report, International Document Updates)Maintenance of the Applicable Standards (ISO 13485, ISO 10993-1:17, etc. )Manufacturing Site Change SubmissionRegulatory Notifications (Notice of Significant Change, Letter to file)Maintenance of Controlled Regulatory Documents(Technical File, Design Dossier, DHF) Preparation of International (Japan, Brazil, Africa, Middle East) Regulatory Packages Containing Numerous Documents (Annual Sterilization Validation, Declaration of Conformity, Manufacturing Floor Plan, All V&V Documentation, PFMECA, DFMECA, etc.)

Prelude Corporation develops in-vitro diagnostic assays to predict the outcome of Ductal Carcinoma In Situ (DCIS).Responsibilities:Diagnostic biomarker assay test developmentPreparation for Validation in a CLIA labLocating micro-toned tissue libraries around the world with traceable outcome dataContacting the responsible parties for potential collaborationLiterature search