Innovation In Motion Through Quality
At QA RA Dynamics, we take a comprehensive approach to quality assurance and regulatory affairs. We work closely with you and your team to identify your Quality or Regulatory needs and ensure the most efficient solution. Our goal is to ensure your products meet all required quality and regulatory standards, while helping you streamline your processes and reduce costs.
Regulatory Quality Consultancy
Services
We support companies through various stages of development, commercialization and post-market activities. Services include Quality Management, Regulatory and Development advice and support across various markets including:
Regulatory
Device Classification
Regulatory planning
Product Registration Pathways
AU Sponsors
Quality
QMS implementation
eQMS transitions
Procedure development
Post market surveillance
CAPA resolution
Product Development
Development GAP assessment
Development planning
Risk management
Useability Engineering
Verification and Validation
Why Choose QA RA Dynamics?
Expertise in Medical Device Quality Assurance
At QA RA Dynamics, we specialize in medical device quality assurance and regulatory affairs. Our team has extensive experience working with ISO 13485 and 21 CFR 820 compliance, and we stay up-to-date with the latest industry regulations to ensure your products meet the highest standards.
Comprehensive Solutions for Your Business
We offer a range of services to help your business meet its quality and regulatory goals. From design and development to quality management, manufacturing and registration – we have the expertise to guide you through the entire process.
Cost-Effective and Efficient Solutions
Our solutions are designed to be both cost-effective and efficient, so you can focus on growing your business. We work with you to develop a customized plan that meets your specific needs and budget.
- nmuller@qaradynamics.com
- Australia, Sydney NSW, 2765 QA RA Dynamics
Contact Info
Our customer service team is here to answer any questions, please use this form or contact us directly via email or phone.