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Quality Management System

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 Emeritus & Board Member of Acera Surgical

Acera’s Quality System was established based upon 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 14971:2019, Medical Devices – Application of risk management to medical devices
  • ISO 13485:2016, Medical Devices – Quality management systems - Requirements for regulatory purposes
Restrata Sheet eIFU
Item # Size & Configuration Coverage (cm2) eIFU
RWM1-0.5X1 1.3 x 2.5 cm sheet 3.25

For a downloadable version of the IFU, please click here:

MKG-20002-14

RWM1-1X1 2.5 x 2.5 cm sheet 6.25
RWM1-1X2 2.5 x 5 cm sheet 12.5
RWM1-1.5X2 3.8 x 5 cm sheet 18.5
RWM1-1X3 2.5 x 7.5 cm sheet 18.75
RWM1-2X2 5 x 5 cm sheet 25
RWM1-3X3 7.5 x 7.5 cm sheet 56.25
RWM1-4X5 10 x 12.5 cm sheet 125
RWM1-5X7 12.5 x 17.5 cm sheet 225
 
Restrata Mesh eIFU
Item # Size & Configuration Coverage (cm2) eIFU
RMESH-1.5x2 3.8 x 5 cm meshed 19 up to 38

For a downloadable version of the IFU, please click here:

MKG-20002-14

RMESH-2x2 5 x 5 cm meshed 25 up to 50
RMESH-3x3 7.5 x 7.5 cm meshed 56 up to 112
RMESH-4x5 10 x 12.5 cm meshed 125 up to 250
RMESH-5x7 12.5 x 17.5 cm meshed 225 up to 450
 
Restrata MiniMatrix eIFU
Item # Size & Configuration Coverage (cm2) eIFU
RMINI-100 100 mg micronized 10 up to 20

For a downloadable version of the IFU, please click here:

 MKG-20007-02

RMINI-250 250 mg micronized 25 up to 50
RMINI-500 500 mg micronized 50 up to 100
RMINI-1000 1,000 mg micronized 100 up to 200
RMINI-2000 2,000 mg micronized 200 up to 400

 

 

Contact us to learn more

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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