solutions & expertise
Medical Devices
Delivering tailored solutions to our clients in order to unlock regulatory hurdles and help them to meet their goals
Quality Systems & Training
Our medical device team possesses comprehensive knowledge and practical experience with various project types. We offer comprehensive support in the management of quality system documentation processes to ensure adherence to regulatory requirements and quality standards for medical device manufacturers.
Our company integrates innovative approaches, world-class scientific principles, regulatory proficiency, and a committed team to deliver medical device regulatory design and development solutions that yield a positive impact on public health and the quality of life for patients.
Guiding You Every Step of the Way
- Assess gaps in Quality System procedures and implementation
- Assist with Quality System documentation development including expert technical reviews of software development procedures
- Perform mock audits
- Provide in-house training on FDA regulatory issues and new policy developments
- Assist with remediation and resolution of compliance issues including those in a Warning Letter, Untitled Letter, or FDA-483.
Book a Consultantion with an Expert
Interested in working together? We would love to hear from you!