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CFR 820, ISO 13481, ISO 14971

Algoryx facilitates meeting the requirements of CFR Part 820, ISO 13486 and ISO 14971.

U.S. Code of Federal Regulations, Title 21, Part 820: Quality System Regulations (QSRs)

Part 820 is a U.S. federal (FDA) requirement that requires medical device companies to follow current Good Manufacturing Practices. Part 820 encourages manufacturers of components or parts of medical devices to follow Good Manufacturing Practices. Algoryx enables organizations to follow the highest level of Good Manufacturing Practices for injection molded parts.

ISO 9001: Quality Management Systems (QMS)

ISO 9001 requires continuous improvement in Quality Management Systems. Algoryx constitutes substantial improvement over alternative, iterative and inefficient technologies.

  • Algoryx’s technology and methodologies constitute a systematic procedure for deploying and achieving consistency in quality processes throughout the entire organization.
  • Algoryx’s technology enables focus on the “critical one instead of the not-so-critical many” a la Deming during development, validation and production.
  • Algoryx’s technology enables an improvement in actual part quality by producing parts with the Predictor Dimension at the Operating Target. This is a whole other category of improvement above and beyond improving quality management systems.

ISO 13485: Quality Management System (QMS) for Medical Devices

ISO 13485 specifically requires that internal and external suppliers to a Medical Device Company:

  1. Have a Quality Management System.
  2. Do risk management through product realization.
  3. Take action to prevent nonconformities.
  4. Ensure that production part dimensions meet specification.

These requirements flow down directly from the Medical Device Company to its suppliers. This position has been recently promulgated and reinforced by the Global Harmonization Task Force that coordinates ISO standards world-wide.

Algoryx makes existing Quality Management Systems more efficient and more effective. Algoryx directly enables meeting the immediately above requirements 2.-4.

ISO 14971: Risk Management for Medical Devices

ISO 14971 applies directly to molders and to mold design. ISO 14971 applies at all stages of the life-cycle of a medical device. ISO 14971 specifically mentions that having a Risk Management System applies during the product realization process (development and validation).

Algoryx meets the specific requirements of ISO 14971 to use valid statistical techniques.

Algoryx, in and of itself, constitutes a technical Risk Management System during part development, validation and production.

Algoryx has a Risk Management Matrix that shows how the Algoryx technology mitigates and manages 40 specific risks during mold development, validation and production.

Algoryx has experience helping Medical Device Companies demonstrate compliance to federal and ISO standards. Please contact Algoryx for more information if you need help or advice in this area.

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