TUV Nord Awards ISO 13485 Certification to Keneric Healthcare

for the Design/Development, Manufacturing and Distribution of Wound Care Products


ALLEN, TexasApril 26, 2018 /PRNewswire/ — Keneric Healthcare’s ISO certification award represents its ability to design, implement, and successfully manage an effective quality management system that meets the requirements of DIN EN ISO 13485: 2012 / EN ISO 13485: 2012 +AC: 2012 – Medical devices – Quality management systems – Requirements for regulatory purposes. The scope of the ISO certification supports the Design/Development, Manufacturing and Distribution of Wound Care Products.


Keneric Healthcare, a global medical device manufacturer, recognized for the development and commercialization of innovative products that improve patient care, increase clinician efficiency and streamline facility expenditures. Product portfolio includes RTD™ Wound Dressing, an FDA cleared, polyurethane silver foam dressing that consistently demonstrates positive clinical outcomes for a variety of wound types; and PurePurge™ Bed bath System, an easy to use rinse-free patient bathing product offering healthcare professionals an ideal and cost-effective solution for bathing patients who are unable to take a traditional bath or shower.

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