Finding out the true potential of your business, together.
Empowering Medical Device Innovation
Providing practical solutions to your regulatory compliance and quality assurance challenges
About Us
Get advice from a professional. Based on years of medical device manufacturing, design, and regulatory affairs experience, we take a practical approach to ensure you remain compliant and manage risk, so you can focus on your key business goals. We are committed to bringing out the best in your work. With QARA Solutions, we'll find out the true potential of your business, together.
Our Services
Services:
1) Manage your quality system, including ISO 13485 and 21 CFR 820
2) Regulatory compliance, including state licensing, international registration support, UDI/labeling, FDA registration, and Health Canada licensing
3) Quality Engineering, including process validations, risk management, and design control
Explore our range of specialized services designed to address your specific needs in regulatory compliance, risk management, quality assurance, and product development for medical devices.