Medical

Devices

OUR SERVICES

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

Development

Our product design and technical staff work with our partner medical device manufacturers to create initial prototype, test and analysis tools to build early stage reference implementations of medical devices. Assessments are conducted regarding the classification of the device for regulatory purposes in the following regions;

  • FDA

  • CE Mark

  • TGA

  • Canada Health

  • Middle East and North Africa

Applied Precision Medicine offers deep expertise across medical device and healthcare related software development for Class 1, Class 2 and Class 3 devices.

  • Development of firmware for Medical Devices

  • Development and integration with Internet of Medical Things (loMT) technologies

  • User experience experts provide GUI and other usability interface solutions

  • Working with scientists and engineers we assist in development of software algorithms

  • ISO-62304 compliant software development for medical device compliance

Our biomedical engineering technicians and engineers work on initial concept selection and feasibility, forming the manufacturing model and optimal approach to building the device. This includes selection of the manufacturers that can provide the product and components in line with the customer's commercial goals. Our specific capabilities cover:

  • Digital, Analogue, Signal Electronics

  • Wearable Portable Devices

  • Technology stacks including RFID, Wi-Fi, Bluetooth

Manufacturing

The diverse nature of our projects and medical devices and their commercial deployments requires careful selection of the optimal manufacturing model to deliver the customer's goals. We evaluate and assess components and sub-assemblies from various manufacturers for product quality and regulatory compliance.

  • Scope customer needs, requirements and desired functionality

  • Requirements management

  • Verification and validation planning

  • Functional Analysis and Modelling

  • Value Engineering

  • Independent Verification and Validation analysis and testing

Clinical

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