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.