Helping YOU Engineer Safe, Effective, Efficient, and Satisfying

Medical Devices and Health Information Systems

We are a healthcare engineering private practice focused on helping you develop & deploy medical devices and health

information systems that are safe, effective, efficient to produce & maintain, and satisfying to all your stakeholders.  Our

principals provide highly personalized service tailored to your specific requirements and constraints.  We have been

serving domestic and international clients since 1997.  Our clients have ranged from global multi-nationals to new

startups, as well as numerous regulatory and technical consulting firms.  We have experience with a very broad range of

medical devices - from accessories for Class 1 devices to untried Class 3 medical devices - as well as serving as expert

witnesses in product liability litigation.  It is our belief that the best defense against medical device product liability is a

structured, systematic, and well-documented product development process compliant with FDA’s QS regulations and

ISO 13485/14971.

We provide: • medical device regulatory assistance with 510(k)s (& e-Copy), IDEs, PMAs, 483s, and MDRs;  • technical and management assistance with the development and implementation of FDA-compliant quality management systems and ISO14971 - compliant risk analysis & risk management;  • assistance with "cradle-to-grave" human factors & ergonomics engineering, including usability & user experience studies; • technical and management assistance with the design, development, and statistically-valid verifications and validations of mechatronic medical devices;  and • complete confidentiality and personal service for all our clients. We are particularly interested in assisting you in the development, deployment, and maintenance of highly safety- critical medical devices and health information systems.  Please browse our website for more information.  Let us know how we and our colleagues may help you.  We are always happy to spend 30-60 minutes chatting with you to ensure that we can assist you.  Please don't forget to check out our e-Library.

Forthcoming Professional Workshops & Presentations

• None at this time; please select e-Library for previous events.