ISO 10993 is a multi-part standard that guides manufacturers through the assessment of potential biological risks of their medical devices. It includes a series of documents covering various testing protocols, such as:
The latest version, ISO 10993-1:2021, emphasizes a biological risk management process in line with ISO 14971 and focuses more on material characterization and in-vitro methods, reducing the need for animal testing.
With increasing global demand for safer and more advanced medical devices, regulatory bodies like the US FDA, EU MDR, and Health Canada require proof of biocompatibility through ISO 10993 compliance. ISO 10993 certification is not just a regulatory need but a strategic advantage that demonstrates your commitment to patient safety and product quality.
Growth Management Corporation ensures that your product development aligns with the requirements of ISO 10993 from the early stages, helping you minimize risks, reduce cost and time-to-market, and improve your chances of global market access.
ISO 10993 consulting by Growth Management Corporation offers multiple strategic business advantages:
✅ Accelerated Regulatory Approvals: Faster clearance from FDA, EU, and other bodies due to proper documentation and biological evaluation.
✅ Improved Product Safety: Early risk detection leads to safer medical devices, minimizing product recalls or legal liabilities.
✅ Global Market Access: ISO 10993 is an essential requirement for exporting medical devices to regulated markets worldwide.
✅ Reduced Development Cost: Proper material selection and testing strategies reduce the need for repeated trials and rejections.
✅ Enhanced Brand Reputation: Certification adds credibility and confidence among healthcare providers and patients.
✅ Aligned with ISO 13485 QMS: Integration with quality management systems ensures end-to-end compliance and traceability.
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Growth Management Corporation is a management consulting firm that provides consulting, training, implementation, and certification services and solutions to organizations of all sizes, and all domains.
