DynaFlex Quality Assurance:

DynaFlex is leading the pack with an ISO 13485:2016 certification for medical devices. This level of Quality Management System certification is among the most difficult and globally recognized certifications to obtain and maintain. DynaFlex supports its quality management system through documented procedures, qualification of personnel, validation of processes and equipment and an emphasis on customer satisfaction and feedback. DynaFlex continues its quality management system preservation with quarterly quality and data analysis meetings, quarterly internal audits, an annual external audit from an ISO certification body, as well as periodic FDA audits.

DynaFlex also complies with the FDA Code of Federal Regulations (CFR) 21 Part 820. The ISO 13485:2016 requirements exceed that of the FDA’s requirements for medical device manufacturers. This gives DynaFlex customers added confidence in the quality, authenticity and performance expectations of the products we provide to our medical professionals.

In addition, DynaFlex is held to another stringent set of directives by having CE markings. CE stands for “Conformité Européene” which translates to European Conformity. Regulated by MDD 93/42 EEC, this is a strict classification of medical devices and their intended use, and requires a manufacturer to uphold their precise set of rules and regulations. By affixing a CE marking to a product, DynaFlex declares that the product meets all the legal requirements for CE marking and can be sold throughout the European Economic Area (EEA) as well as national and other international markets. DynaFlex is actively working toward certification under an even more challenging direction. The EU Medical Device Regulation 2017/745. With an even greater emphasis on product traceability, clinical effectiveness and post market surveillance, DynaFlex continues its commitment to excellent quality and reliable conformity of its products.

The Quality Assurance and Regulatory Affairs (QA/RA) department is devoted to upholding all aspects of these certifications and regulations. DynaFlex has a well trained and certified team in place to consistently monitor the Quality Management System and continue the verification of its effectiveness.

For any Quality or Regulatory Affairs matters, please reach out directly to Matt Malabey at mattm@dynaflex.com


ISO 13485 Medical Certification

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CE 1304

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