KL Baker MedTech Consulting, LLC
Ken Baker, Founder and Consultant, Medical and diagnostic system product development.
No one likes developing user needs and system requirements, right? I do, so let me help you with yours. You bring the idea, I’ll write system requirements and develop the system architecture so that the entire development team has a common and complete understanding of what it is they are developing.
I can also help with safety risk management per ISO 14971, electrical safety standards (60601 series, 61010 series), verification and validation planning and management, liason with third party test houses,
Contact me at ken@klbakermedtech.com.
Services
Development of system user needs and system requirements
Development of system architecture, both physical and behavioral
Requirements allocation and traceability
Assessment of 60601 or 61010 series applicability, clause by clause
Review of existing system and subsystem design documentation
About Ken
I have 31 years of experience in medical and IVD product development, 30 patents.
I have done development work in implantable defibrillators, neurostimulation devices, and a large variety of class 2 and class 3 external devices.
I am familiar with the 60601 and 61010 series of safety standards, as well as 14971, FDA regulations, and others.
I can work remote for businesses anywhere in the US.
KL Baker MedTech Consulting, LLC
Ken Baker, consultant, medical and diagnostic device product development
- 4224 Edinbrook Terrace, Brooklyn Park, Minnesota
- ken@klbakermedtech.com
- 612-202-4114