CERTIFICATIONS

These certifications provide the customer with assurance of safe, effective products of the highest quality.

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FDA Information

All Myotronics devices are registered with the U.S. Food and Drug Administration and have received permission for marketing under 510(k) pre-market notifications.

Dates and FDA document control numbers for all instruments are listed below:

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ISO Information

Since 1998 Myotronics-Noromed's Quality Systems have been continually audited and approved by independent auditors authorized by National Accreditation Bodies. The Company is currently certified to ISO-13485. All major products meet the additional safety and efficacy requirements of that organization which permit affixing the "CE" mark to the products.

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Quality Policy

Myotronics-Noromed, Inc. is committed to manufacturing quality products, backed by strong service support, that satisfy customer requirements. Products are designed and manufactured to meet current legal and regulatory standards. To ensure a high level of customer satisfaction, the Company maintains a quality system designed to actively monitor and continually improve its products, services and the quality system itself.

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Canadian Credentials

Medical Device Establishment License #3429
Canadian Device License # 3070 (J4/J5/BNS-40)
Registered to ISO-13485: 2016 MDSAP