Plexus RA Pty Ltd

Plexus RA Pty Ltd provides specialist clinical, regulatory and quality consulting services to clients involved in the manufacture, supply, use or approval of medical devices in Australia and NZ, as well as US and Europe.

From start-ups initially entering the market to established companies with extensive product portfolios, we use a risk-based, customised approach to efficiently and effectively achieve your organisation’s objectives.

Key services provided include:
– Australian local sponsorship / TGA representative
– Early Strategic Planning and Advice
– Project Management
– Technical Files and Design Dossiers
– Regulatory Submissions
– Post-market Compliance
– Quality Management System
– Labelling and Promotional Material
– Training and Education

Company’s Keywords:

medical device regulatory expertise, clinical trial expertise, australian medical device local sponsor, iso 13485 internal auditing, iso 13485 qms implementation