Medical Devices / Diagnostics

With our extensive knowledge of the regulatory and compliance environment, we will enhance your competitive advantage while strengthening your bottom line.  Nopras Technologies personnel average over 20 years of experience in product life cycle; from design, laboratory analysis, clinical development, through manufacturing and product tracking. Our risk-based approach to solving regulatory compliance issues is well-suited to the medical device industry.

Whether you are developing a new product, improving an existing product, or trying to comply with the numerous regulations and standards, Nopras Technologies services will accelerate your success.
Our consulting services have been designed to address any areas involving regulatory or quality requirements as mandated by the FDA regulations and international standards, including 21 CFR Parts 210/211, 820, QSR, ISO 13485 and 14971.

Nopras Technologies services for the Medical Devices/Diagnostics Industry include:

• Program Design
• Product Development
• Operational Excellence
• Regulatory Preparation and Submission
• Regulatory Compliance and Quality Management
• Clinical Operations Excellence
• Validation Protocol Development and Execution