5 Medical Device Best Practices For Managing Risk To Users, Patients, And The Environment

By Nicolle Cannon, Founder & CEO, Cannon Quality Group

Medical device companies of all sizes are often concerned about speed-to-market, new device clearance overhead costs to maintain compliance, and lack of certainty about what is needed to maintain compliance, and fear of non-compliance consequences.

Taking a risk-based approach can alleviate these concerns and simplify adherence to numerous compliance requirements established by regulatory bodies such as:

• U.S. Food and Drug Administration (FDA)
• Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK)
• European Union Medical Device Regulation (EU MDR)
• International Organization for Standardization (ISO)
• Therapeutic Goods Administration (TGA) in Australia

Meeting these compliance standards and following the best practices explained in this article are key to bringing new medical devices to market with success.