Meeting International Regulatory Standards
Why comply with ISO 13485?
The International Organization for Standardization (ISO) is a global regulatory organization that brings leaders across the world together to set quality standards for the medical device industry. Since the FDA has made the final rule to harmonize the 21 CFR Part 820 Quality System Regulation (QSR) U.S. standard with ISO 13485 international regulations, manufacturers need to ensure their quality system meets both.
Incorporating ISO 13485 standards can enhance quality, and broadens your medical device market. It also ensures your company is prepared for the imminent transition from the FDA QSR to the updated QMSR (Quality Management System Regulation).
DP Distribution & Consulting, LLC® provides ISO 13485 consulting to help companies become ISO 13485 compliant by assessing the gaps in your current quality system. We help determine the most cost effective and concise conversion strategy for your team, so your QA/RA needs are adequate and not overburdensome.
For guidance on attaining or maintaining ISO 13485 compliance, DPDC medical device regulatory experts are available to support your process. Reach us via the form, or at 804-965-3981.
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