Quality Management System Consultancy & Solutions

We can provide temporary or structural pragmatic solutions and support with building or improving your Quality Management System according to ISO 13485 and regulations.

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Internal Audits, Supplier Audits & Notified Body Audits

Auditing can be a comprehensive and time consuming aspect in quality management. We can perform internal audits, supplier audits and take the lead during a Notified Body audit for you. ISO 9001 - ISO 13485 - MDR - IVDR

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Regulatory Consultancy & MDR / IVDR Requirements for QMS

We can guide manufacturers, distributors and importers and even logistic service companies of class I or higher medical devices in building their QMS according to applicable MDR / IVDR and ISO 13485 requirements.

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At NDK Compliance & Design, we can provide Quality & Regulatory Consultancy and Solutions to
early-stage startup companies as well as well established companies, customized to their needs.

At NDK Compliance & Design we believe there is beauty and fun in quality, no matter what department. Product Development, Logistics, Maintenance, Human Resources, Top Management. Wherever the company goes, Quality accompanies this journey. At NDK Compliance & Design we will provide customized consultancy and pragmatic solutions for your journey in Quality Management and/or Product Quality.