R&Q Consulting provides services in Quality Systems and Regulatory Affairs for companies in the medical device industry compliant with the international standard ISO 13485:2016, the EC Directives, Canadian Medical Device Regulations and the FDA Quality System Regulations.
We enable you to quickly and effectively obtain certification for your Quality Management System (QMS) and products in line with your company strategy and goals.
With our practical, down to earth approach, we accompany you, at the pace you require, through the different set up and implementation stages as your company develops and grows.
Company’s Keywords:
review of sterilization validation as part of submission files, train on qms requirements, set up implement quality systems, prepare sterilization protocolsreports, perform audits, assist in preparing documentation for regulatory sumbissions, set up amp implement quality systems
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