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Medical Device Consulting

Regulatory Services

 

  • Quality Management System

  • FDA Premarket Notification

  • Medical Device Risk Management

  • Alarm Management

 

Development Services
  • Product and Market Research

  • Requirements Development

  • Usability

  • Technical Writing

 

Marketing Services

 

  • Marketing Campaign Design

  • Product Launch

  • Product Management

  • Product and Sales Training

  • New Business Development

  • Contract Negotiations

ABOUT US

With 40 years in the medical device industry working with Software as a Medical Device, Mobile Medical Applications, Multi-Parameter Patient Monitoring, Wireless Telemetry, Medical Device IT Networks, Electrocardiography, and Arrhythmia systems. SCG has a history of effective interaction and relationship management with clients, sales management, research and development, engineering, creative agencies, and multi-functional project teams.  Coupled with strong analytical and development skills, SCG can help you achieve success whether its working with, or creating a Quality Management System, FDA Premarket Notification, Medical Device Risk Management, Project Management, Technical Writing, and more.  

Principal Consultant Bob Steurer is a member of the IEC/ISO/AAMI/ANSI Medical Device Alarms Committee, the AAMI Committee on Artificial Intelligence, ISO TC121, JWG2 Alarms, IEC 80001-1: 2014 Application of risk management for IT Networks incorporating medical devices, and AAMI/ANSI/IEC 60601-2-25 Particular requirements for the basic safety and essential performance of electrocardiographs, as well as other standards development committees.  Knowing the standards and applying them in product development can ensure best in class as well as regulatory compliance around the globe.

CONTACT US

Steurer Consulting Group

Located in the

Dallas/Ft. Worth Metroplex

info@scgconsulting.net

Tel: +1 425-358-1072

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