QUALITY POLICY

DANNIK is committed to developing and delivering reliable and effective medical devices to the highest quality standards for the patients we serve.  Through the vigilant implementation and maintenance of our quality management system, we are committed to exceeding the expectations of our customers, users and patients.

DANNIK’s commitment is achieved through:

·       Compliance and Quality Management

Complying with applicable quality, safety and regulatory requirements and maintaining the effectiveness of the quality management system.

·       Customer Focus and Support

Valuing customer success while providing unmatched product expertise, technical support, responsiveness and service.

·       Products

Continually developing and innovating to provide leading edge technologies at the highest quality and value.

 As the medical device regulatory landscape continues to evolve, DANNIK maintains an unparalleled commitment to meeting and exceeding the regulatory requirements by maintaining an ISO 13485:2016 certified Quality Management System in compliance with current Good Manufacturing Practices (cGMP) as defined by United States Code of Federal Regulations Title 21 for the Food and Drug Administration (21 CFR §820)

We recognize that Regulatory compliance for our medical devices is a continuum that begins at the inception of the device all they way through its entire life-cycle, and beyond.   Below, please find some supporting Regulatory data relating to our range of products.