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My passion for start-ups has taken me on a journey that spans across companies in regulated medical devices (including SaMD), AI-powered analysis, digital therapeutics, digital healthcare, eCommerce, eDiscovery, digital ticketing, and application provisioning. I had the opportunities to play many different roles and wear many different hats. I am proud to be part of five start-ups that resulted in M&A or IPO: CenterRun (acquired by Sun Microsystems ), Clearwell (acquired by Symantec), Relsys and goBalto (both acquired by Oracle) and Pear Therapeutics is now a public company. I enjoy working to bring products through regulatory submissions and ultimately release to market. I am very excited to continue this journey on a mission to save lives!
Cardiosignal By Precordior
View- Website:
- precordior.com
- Employees:
- 30
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Cardiosignal By Precordior -
Vp Regulatory AffairsCardiosignal By Precordior Mar 2024 - PresentTurku, Southwest Finland, FiWe are a health technology company based in Finland and the United States. Today, our patented technology enables a digital cardiac biomarker for several major heart disease, representing a disruption in battling heart disease, the costliest and deadliest disease in the world. -
Vp Regulatory Affairs And Quality AssuranceStealth Mode Startup Nov 2022 - Oct 2023San Francisco, Us -
Vp Of Regulatory & Quality (Samd, Ai)Cleerly, Inc. - Heart Disease Technology Jun 2021 - Nov 2022Our Mission: To create a new standard of care for coronary artery disease that can help prevent the millions of heart attacks that occur worldwide every year.MDSAP & ISO 13485 CertificationFDA De Novo SubmissionCompany raised $223M Series C
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Vp Quality & Regulatory Affairs (Samd, Medical Device, Ai)Eko - Stethoscope Technology Aug 2018 - Jun 2021Emeryville, California, UsEko brings together advanced stethoscopes, patient and provider software, and AI-powered analysis—elevating the way we detect and monitor cardiovascular disease. Through this unified platform, our mission is to help clinicians drive the next evolution in cardiac care.Hands-on leadership to achieve the following accomplishments:- MDSAP Certified- MDD Certified- ISO 13485:2016 Certified- FDA Cleared (CORE: Rx and OTC, DUO & Algorithm)- CE Marked Products- Health Canada approved- TGA (Australia) approved -
Director Of Compliance And Quality Management (Samd)Pear Therapeutics Aug 2016 - Jul 2018Pear Therapeutics (IPO 2021) is a public eHealth company with offices in Boston and San Francisco developing drug/software combination products to address a broad range of severe conditions. The company’s eFormulationTM platform combines pharmaceutical preparations with user-friendly, customizable, and scientifically validated software applications. Pear’s patented approach provides better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payors. For additional information please visit our website at www.peartherapeutics.com.- FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs (reSET-O)- FDA permits marketing of mobile medical application for substance use disorder (reSET)- Software Pre-certification Pilot Program Participants
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Platform Product ManagerPear Therapeutics Jun 2015 - Aug 2016Pear Therapeutics is a privately held eHealth company with offices in Boston and San Francisco developing drug/software combination products to address a broad range of severe conditions. The company’s eFormulationTM platform combines pharmaceutical preparations with user-friendly, customizable, and scientifically validated software applications. Pear’s patented approach provides better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payors. For additional information please visit our website at www.peartherapeutics.com.
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Vp ProductDabo Health, Inc. Mar 2013 - Apr 2015Dabo Health is a tool for nurses, doctors, hospital administrators, and other hospital affiliates to help improve the quality of patient care.Dabo provides the healthcare community a platform to view and track improvement in key performance metrics, to collaborate across hospitals and healthcare systems, and to identify and share evidence based best practices in order to save lives.Accomplishments: - Joined the founding team - built the team and product- Created, shared and maintained company product roadmap- Built the product to successfully complete the pilot at the Mayo Clinic- Built background learning content from Center for Medicare & Medicaid Services (CMS) value basedincentive programs (Value Based Purchasing, Readmission Reduction Program, Hospital AcquiredConditions, Surgical Care Improvement Project)- Built product requirements that includes background content (such as CMS regulation), detailed datarequirements, graphical data presentation and compliance security requirements- Provided IT internal networking and computing support for everyone in the company -
Senior Director Of Quality Assurance, AdvisorGobalto, Inc Sep 2011 - Jan 2013(Acquired by Oracle in 2018)Accomplishments: - Built QA team- FDA 21 CFR part 11 compliance completed in December 2011- Built product roadmap and vision- Built automation (Ruby, Rspec, Capybara, Selenium Webdriver)- Successful vendor audits- Partnership with top-ten CROs and Pharmaceuticals
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Director, Quality AssuranceVeritix Mar 2007 - Sep 2011Accomplishments: - Built QA team (Dallas and Campbell)- Built automation- PCI compliance- Streamlined process across Campbell, Dallas and Cleveland- On-site implementation at Quicken Loans Arena, Pepsi Center, San Francisco 49ers -
Director, Quality EngineeringClearwell Systems Aug 2005 - Feb 2007Mountain View, Ca, UsAccomplishments (acquired by Symantec May 2011): - Built QA team (US and India)- Built QA lab with 40 servers- Built automation (nightly test automatically executed)- Performance testing with 4 million data set with index of 1.2 million emails -
Quality R&D ManagerSun Microsystems Aug 2003 - Jan 2005Palo Alto, Ca, UsRole: Manager, Quality R&DAccomplishments: - Managed N1 Services Provisioning and N1 Integration Product QE teams- Sucessfully delivered N1 Services Provisioning System 4.1- Scaled the team by doubling the size of the QE team -
Director, Quality AssuranceCenterrun Feb 2001 - Aug 2003Accomplishments (acquired by Sun August 2003): - Built QA team and delivered enterprise product- Set up and implemented Quality Assurance process and a defected tracking system which included a bug tracking process – as a results, delivered all releases on time- Worked with Sun Microsystems acquisition team to transition the CenterRun team to Sun Microsystems. Sun Microsystems acquisition team was very impressed with the quality of the CenterRun product and the well-established engineering process (development and QA processes)
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Director, Quality EngineeringDelano Technology Nov 2000 - Feb 2001CaAccomplishments: - Set up Quality Assurance processes and improved the bug tracking process- Trained the Quality Assurance team on processes and communication- Work with Quality Assurance in Toronto to integrate processes and product- Offered a QE Director position in Toronto to manage QE team of 41 people which included 4 QE managers -
Director, Quality AssuranceRivio Apr 2000 - Nov 2000Accomplishments: - Constructed and implemented Software Quality Assurance process which included: system testing, integration testing, performance testing, regression testing- Trained quality assurance engineers on the Software Quality Assurance process- Participated in usability testing to gather and analyze feedbacks from customer
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Director, Global Professional Services; Director, Quality Assurances; Product Manager; Co-FounderRelsys International Dec 1992 - Apr 2000UsSummary (acquired by Oracle March 2009, Oracle Argus is considered the gold standard in safety):- Joined Relsys (a start-up company) as a Co-Founder of the company and helped build the company from a consulting firm to a product company that ultimately became profitable.- Built Relsys Argus Safety to be the best in-class product and as a result, Relsys was acquired by Oracle in March 2009.- Relsys went from 4 employees to over 40 employees and was recognized as the Deloitte & Touch 50 Fastest Growing Company in Orange County.- Established Relsys’ very successful product deployment division across Europe and USAAccomplishments: - Managed three major accounts that accounted for over $5 million.- Successfully deployed the implementation of Global (United States, Sweden and Italy) Adverse Events Handling System at Pharmacia ($4 million project). The successful completion of this project helped launch a $6 million business opportunity for Relsys. - Successfully deployed the implementation of Global Adverse Events Handling System at Quintiles ($1 million project) and Kendle ($0.5 million project). - Managed software development project for Medical Device Manufacturer that had six processors and a team comprised of 15 people- Received an award from Pharmacia for the successful implementation of the Global Adverse Events Handling System- Built a Quality Assurance team for Relsys (a start-up company) and successfully delivered over 200 software validation and verification as well as software development projects. Successfully managed and passed all vendor audits of Relsys’ software development and quality processes by all pharmaceutical companies- Developed, managed and audited ISO 9000 processes at Relsys- Built a successful drug safety product (Argus Safety) that was sold to many of the top ten pharmaceuticals- Argus Safety became the most advanced drug safety and risk management solution
Phu Trinh Skills
Phu Trinh Education Details
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California State Polytechnic University-PomonaElectrical Computer Engineering -- Graduated With Honors
Frequently Asked Questions about Phu Trinh
What company does Phu Trinh work for?
Phu Trinh works for Cardiosignal By Precordior
What is Phu Trinh's role at the current company?
Phu Trinh's current role is VP of Regulatory & Quality Affairs (medical device, SaMD, AI).
What is Phu Trinh's email address?
Phu Trinh's email address is ph****@****aol.com
What is Phu Trinh's direct phone number?
Phu Trinh's direct phone number is +141520*****
What schools did Phu Trinh attend?
Phu Trinh attended California State Polytechnic University-Pomona.
What skills is Phu Trinh known for?
Phu Trinh has skills like Agile Methodologies, Automated Software Testing, 21 Cfr Part 11, Quality Assurance Methodology, Enterprise Software, Software Engineering, Software Development, Cloud Computing, Quality Assurance, Test Automation, Testing, Software Quality Assurance.
Who are Phu Trinh's colleagues?
Phu Trinh's colleagues are Jukka Mäkelä, Heini Saari, Tero Tapiovaara, Mia Koutu, Lasse Suvanto, Tuomas Valtonen, Kamal Jafarian Dehkordi.
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