We support organizations from early development through post-market phases and help launch products to the market. We also support with designing, establishing and execution of complete Quality Management System (QMS).
We offer end-to-end engineering and compliance solutions to develop risk management and design control strategies for all life cycle stages of medical devices and combination products.
We are highly experienced in the strategy and system development and maintenance of Quality Management Systems (QMS) which are compliant with USA FDA and other various International regulations such as Europe, Australia, Japan, and Canada.
We help determine missing elements from your current systems, identify and support implement changes needed in existing systems.
We can help your organization implement and maintain systems critical to your product and process.
We also provide services in other Quality system elements such as continuous improvement in Corrective and Preventative Actions (CAPA), Change Control, Deviations/Investigations Design Controls, and Risk Management.
We also design and implement process flows and improvements related to Complaints/Adverse Events, Document and Records Management, Training, Internal Audits, and Supplier Management
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