Personal Information
Organization / Workplace
San Francisco Bay Area United States
Occupation
Lean & Compliant Medical Device Development
Website
www.consensiainc.com
About
Biomedical engineer with over 20 years of experience in medical device development over a wide range of technologies, from surgical robotics to x-ray imaging systems to catheters to drug inhaler devices. Broad experience implementing and managing design controls, from work at small startups to global corporations.
Experienced in the following areas:
· Incorporating lean and agile methods into medical device development
· Implementing requirements management tools for streamlined compliance
· Design verification and validation testing (V&V) for software and hardware
· Writing and managing product requirements, software requirements, hardware requirements
· Risk management for new product...
Tags
design controls
medical devices
risk management
agile software development
fda
lean product development
quality system
software testing
cost of change
cybersecurity
iot
agile
iso 14971
iso 13485
regulatory
compliance
a3 method
See more
Presentations
(4)Likes
(1)Mobile Is Eating the World (2015)
a16z
•
8 years ago
Personal Information
Organization / Workplace
San Francisco Bay Area United States
Occupation
Lean & Compliant Medical Device Development
Website
www.consensiainc.com
About
Biomedical engineer with over 20 years of experience in medical device development over a wide range of technologies, from surgical robotics to x-ray imaging systems to catheters to drug inhaler devices. Broad experience implementing and managing design controls, from work at small startups to global corporations.
Experienced in the following areas:
· Incorporating lean and agile methods into medical device development
· Implementing requirements management tools for streamlined compliance
· Design verification and validation testing (V&V) for software and hardware
· Writing and managing product requirements, software requirements, hardware requirements
· Risk management for new product...
Tags
design controls
medical devices
risk management
agile software development
fda
lean product development
quality system
software testing
cost of change
cybersecurity
iot
agile
iso 14971
iso 13485
regulatory
compliance
a3 method
See more