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Regulatory Services

  • Quality Management System

  • FDA Premarket Notification

  • EU MDR 

  • Medical Device Risk Management

  • Alarm Management

  • Post-Market Surveillance

 

Development Services
  • Product and Market Research

  • Design Controls Management

  • Requirements Development

  • Usability

  • Technical Writing

 

Marketing Services

  • Marketing Campaign Design

  • Product Launch

  • Product Management

  • Product and Sales Training

  • Competitive Analysis

  • New Business Development

ABOUT US

With 45 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 Working Groups updating ISO 60601-1 to the fourth edition. 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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