Our Professional Services
DevDx is committed to providing best-in-class compliance consulting services dedicated to the medical device, digital, diagnostic and health research sectors. Our service offerings extend across the entire product development life cycle.
Leveraging the individual and collective expertise of our team and partners, DevDx offers an end-to-end consulting service through a single point of contact.
Depending on your needs and budget you can select any or all our services at any entry point in the product life cycle without seeking out individual consultants.
We ensure that our solutions are flexible, personalised, fit for purpose, fully compliant and cost effective.
We have an extensive portfolio of successful project delivery with a focus on the establishment and implementation of ISO 13485/21 CFR 820 and EU MDR/IVDR- compliant quality management systems (using a variety of software and paper-based solutions); the development and implementation of global (often parallel) regulatory submissions leading to CE mark, FDA registration and inclusion on the ARTG, and the development and implementation of global clinical research strategies and trials.
We have implemented 15 Quality Management Systems for Australian start-up companies and research/academic institutions. If you are interested in implementing your own QMS, DevDx now has available in our Document Library a full suite of Policies, Procedures, Forms and Templates that will enable you to implement and manage an ISO 13485:2016, 21 CFR 820, MDR/IVDR compliant Quality Management System
The value proposition of using DevDx is that “we have done it successfully many times before, we know what is required in a start-up environment, and the importance of working to tight deadlines in a limited resource environment.” We have an excellent reputation for accelerating the process using a cost-effective but fully compliant model. We fully understand the importance of working with a single-product company.
