MEDICAL

Devices

OUR SERVICES

Applied Precision Medicine is a trusted partner for medical device startup companies looking to commercialise their technology.

 

Complexity of regulatory requirements are a challenge for medical device developers. Our regulatory consulting team provides input to all parts of the development and manufacturing processes. This means that preparation for clinical validation is easier.

  • Regulatory assessment and corrections to new regulatory requirements

  • Preparation of regulatory submission

  • Emerging markets regulatory support

  • Standards Compliance

Our Quality Management System (QMS) implementations are driven by Total Product Lifecycle Management. 

  • Implementation of Product Lifecycle Management (PLM)

  • Embedded Quality and Improvement Management System

  • Third-Party supplier and manufacturer control and dedicated portals for integration

©  Copyright 2012 - 2019 Applied Precision Medicine Pty Ltd