Lake Region Medical

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Certifications & Standards

Lake Region and all of its employees are committed to the highest standards of quality, delivery and service of our products to all our customers. In our pursuit, we've achieved the following certifications:

Lake Region Medical QMS Letter
Arvada, CO: EN ISO 13485:2003/AC:2009: 11.26.2014-08.18.2018
Arvada, CO: ISO 13485 2003: 11.17.2014-09.07.2017
Aura, Germany: EN ISO 13485:2003/AC:2009: 05.01.2015-04.30.2018
Aura, Germany: EN ISO 13485:2003/AC:2009 DE: 05.01.2015-04.30.2018
Aura, Germany: ISO 9001:2008: 05.01.2015-04.30.2018
Aura, Germany: ISO 9001:2008 DE: 05.01.2015-04.30.2018
Brimfield, MA: EN ISO 13485:2003/AC:2009: 11.26.2014-10.24.2017
Brimfield, MA: ISO 13485:2003: 11.17.2014-09.08.2017
Brooklyn Park, MN: EN ISO 13485:2003/AC:2009: 11.26.2014-10.24.2017
Brooklyn Park, MN ISO 13485:2003: 11.17.2014-09.07.2017
Chaska, MN: EN ISO 13485:2012: 12.10.2014-07.24.2016
Chaska, MN: ISO 13485:2003 CMDCAS: 09.09.2015-06.24.2016
Collegeville, PA: EN ISO 13485:2003/AC:2009: 11.26.2014-09.25.2017
Collegeville, PA: ISO 13485:2003: 11.17.2014-09.07.2017
Collegeville, PA: AS 9100C: 10.9.2014-10.9.2017
El Paso, TX: ISO 13485:2003: 11.17.2014-09.15.2017
Galway (Brivant), Ireland: EN ISO 13485:2003: 10.04.2014-10.03.2017
Galway, Ireland: ISO 13485:2003: 02.25.2015-09.08.2017
Juarez, Mexico: EC-Certificate JRZ/GLW: 11.26.2014-05.19.2017
Juarez, Mexico: EN ISO 13485:2012/AC:2012: 12.04.2014-12.03.2018
Juarez, Mexico: ISO 13485:2003: 3.13.2015-5.22.2016
Laconia, NH: EN ISO 13485:2012/AC:2012: 11.26.2014-06.17.2016
Laconia, NH: ISO 13485:2003: 11.17.2014-07.08.2017
New Ross, Ireland: EN ISO 13485:2012: 06.12.2015-06.11.2018
New Ross, Ireland: ISO 13485:2003: 06.12.2015-06.11.2018
Orchard Park, NY: EN ISO 13485:2003/AC:2009: 12.05.2014-12.04.2017
Orchard Park, NY: ISO 13485:2003: 11.17.2014-10.06.2017
Penang, Malaysia: EN ISO 13485:2012 +AC 2012: 01.03.2015-01.02.2018
Penang, Malaysia: 9001:2008: 1.12.2015-01.11.2018
Salem, VA: EN ISO 13485:2012/AC:2012: 11.26.2014-07.18.2016
Salem, VA: ISO 13485:2003: 11.17.2014-07.14.2016
Trenton, GA: EN ISO 13485:2012/AC:2012: 11.26.2014-12.21.2016
Trenton, GA: ISO 13485:2003: 2.18.2015-05.31.2017
Upland, CA: EN ISO 13485:2003/AC:2009: 12.01.2014-11.30.2017
Upland, CA: ISO 13485:2003: 11.17.2014-10.19.2017
Wheeling, IL: EN ISO 13485:2003/AC:2009: 11.14.2014-11.13.2017
Wheeling, IL: ISO 13485:2003: 11.17.2014-10.06.2017
Wilmington, MA: EN ISO 13485:2012/AC:2012: 11.26.2014-06.17.2016
Wilmington, MA: ISO 13485:2003: 11.17.2014-07.09.2016

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Commitment to Quality

Lake Region Medical’s commitment to quality ensures that its products and services meet or exceed the highest standards set by the United States Food and Drug Administration, the European Community and other internationally recognized agencies. Lake Region Medical has earned ISO 13485, CE Certifications as well as other international symbols of quality system assurance and compliance.

Lake Region Medical has established an industry-wide reputation for its high quality standards through enforcement of stringent design and inspection requirements. This provides customers the added security in knowing that the most sophisticated quality requirements are inherent in all aspects of Lake Region Medical’s business practices.

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