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Compliance

Acera is Committed to Setting the Standard for Quality and Compliance

Our Quality Policy: Acera Surgical is committed to patient safety and will provide high quality medical devices, while meeting or exceeding all regulatory requirements and customer expectations, by thoughtfully monitoring the effectiveness of the quality system, and continually improving product and process performance. 

Setting the highest standards in the market for ethics and the way our company behaves is extremely important.

- Jake Wilson, CEO

Acera’s Quality System was established to meet the requirements of the following regulations and standards:

  • United States Food and Drug Administration (FDA), Quality System Regulation, 21 CFR Part 820 and its referenced parts
  • ISO 14971:2012, Medical Devices – Application of risk management to medical devices
  • ISO 13485:2016, Medical Devices – Quality management systems - Requirements for regulatory purposes
  • Medical Device Directive Council Directive 93/42/EEC as amended by Directive 2007/47/EC

Contact a surgical account executive today!

Contact us today to learn more or request a product demonstration.
Revolutionizing Healing. Changing Lives.
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Cerafix®, Covora®, and Restrata® are registered trademarks of Acera Surgical Inc.
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