consultingmedtech
 

R&D Strategy

•Design concept evaluation

•Technology assessment

•Development & testing strategy

•Manufacturing strategy

•Product development process

Program Management

•Work breakdown structure

•Schedule development

•Visual Management

•Monitoring systems

•Project rescue

Quality Management Systems

•QMS assessment & remediation

•ISO 13485 implementation

•SOP development


Risk Management & Design Assurance

•ISO 14971 Implementation

RMF review

FMEA / Fault Tree / Hazard Analysis

Overall risk evaluation

Product Development

•Design input management

•Preclinical research

•Concept realization

•Product design

•Software & App development

•Systems integration and testing

Mergers & Acquisitions Support

IP review

Design analysis

Clinical efficacy review

Manufacturing capability analysis

DHF assessment