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All-in-one Software Solution and Expert Consulting for Medical Device and Drug Combination Product Design Controls, Risk Management, Cybersecurity, and Safety Assurance Cases
PharmaEd Combination Product Summit May 2023 : CASE STUDY -- Reduce schedule and regulatory risks through proactive safety and effectiveness assurance
Drug Delivery Summit Feb 2023: How to Select (Or Design) The Delivery Technology That Is Right for the Drug
PharmaEd Pre-filled Syringe & Autoinjector Forum: Apply Safety Engineering to Drug Delivery Medical Devices December 1-2, 2022, La Jolla, CA
PDA Course: Drug Delivery Device Combination Product Risk Management and Safety Assurance Cases October 20, 2022, Palm Springs, CA
PDA Course: Drug Delivery Device Combination Product Risk Management and Safety Assurance Cases October 20, 2022, Palm Springs, CA
PDA Course with FDA: Cybersecurity Risk Management for Drug Delivery Combination Products September 20, 2019, Washington, DC
Pre-filled Syringes Forum: Platform-Based Drug Delivery Combination Product Risk Management: Challenges and Best Practices September 4-5, 2019, San Diego, CA
PDA Course: Drug Device and Combination Product Risk Management and Safety Assurance Cases August 15, 2019, Washington, DC
DIA CMC Workshop: Drug Delivery Combination Product Risk Management: Challenges, Principles, and Best Practices April 24, 2019, DC
2018 PDA Combination Products Workshop Oct 10, 2018 Orlando, FL
2018 SoftwareCPR Public Training Course - 62304 and emerging standards impacting Medical Device software and Health IT, Wed, January 24 2018, Sunnyvale, CA
Cybersecurity Workshop with FDA Xavier Health University, October 23-24, 2017
Safety Assurance Cases for Combination Products with FDA PDA Course, Sep 27 - Sep 28, 2017 PDA Training & Research Institute | Bethesda, MD
How to Manage Cybersecurity Risks in Leveraging Safety Risk Management Practices AAMI Webinar Thursday, Feb 16 2017, 11:00 am-12:30 pm Eastern
SoftwareCPR Public Training Course - IEC 62304 and emerging standards impacting Medical Device software and Health IT Tue, January 31 2017, 8:00 AM - Thu, February 02 2017, 4:30 PM [EST] 124 S. Franklin St, Tampa, FL
MEDICAL DEVICE SECURITY 101 CONFERENCE (JANUARY 15 - 17, 2017, LAKE BUENA VISTA, FL)
2016 PDA Drug Delivery Combination Products Workshop (October 19, 2016, Huntington Beach, CA)
Annual Updates with FDA: Assurance Cases for Medical Devices: AAMI Webinar Aug 10, 2016, 11:00am-12:30pm Eastern, Online
Safety Assurance Cases for Medical Devices: AAMI Course Nov 16~17, 2015 Arlington, VA
Software and Cybersecurity Risk Management for Medical Devices: Workshop with FDA Oct 14~15, 2015 Rockville, MD
Cybersecurity for Healthcare and Medical Devices: Conference Session Chair Sep 30~Oct 1, 2015 Minneapolis, MN
Integrate Cybersecurity into Medical Device Risk Management: Tutorial at 3rd Annual Archimedes Medical Device Security Workshop May 5, 2015 Ann Arbor
Risk Management for Implantable Drug Delivery Pumps: Speaker at NANS annual Conference with FDA Dec 11, 2014 Las Vegas
Integrate Cybersecurity into Medical Device Risk Management: Speaker for 2014 RAPS Session The Regulatory Convergence 30 September, 2014 Austin Convention Center in Austin, Texas
Integrating Risk Management into the Quality System: AAMI Course September 17-19, 2014 Arlington, VA 22203
Medical Device Risk Management and Safety Assurance Cases: AAMI Webinar with FDA
August 28, 2014 (11:00am~12:30pm ET) Online
How to Prepare for, Manage, and Follow-up to an FDA Inspection: Risk-driven Approach: Seminar with former FDA Director of Compliance August 7, 2014 - August 8, 2014 San Jose, CA
Software and Cybersecurity Risk Management for Medical Devices-Learn Best Practices from FDA and Industry Experts: Workshop with FDA May 21, 2014 – May 22, 2014 Doubletree Bethesda Hotel Bethesda, MD
Safety Assurance Cases for Medical Devices: AAMI Course April 8, 2014 – April 10, 2014 Arlington, VA 22203
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