Services
Quality Management:
We provide support and expertise to Business & Quality Leadership in areas such as Quality Department Organizational Structure and Design, Strategic Quality Planning and Coaching/Mentoring.
Quality Culture:
A Quality Culture is key to any organization involved with Medical products and services. We provide solutions to foster not only a quality and compliance mindset but also cultivate continuous improvement and excellence at every level in your organization.
Compliance Assessments:
We evaluate your Quality Management System and practices to identify areas of opportunity or concern to ensure efficient operations and adherence to regulatory standards.
Quality Systems:
We specialize in the design and implementation of robust quality systems adhering to FDA 21CFR820 and ISO13485 standards. We meticulously analyze your processes and procedures and provide practical, risk appropriate solutions tailored to your business.