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
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