Having a quality management system is one of the first steps to your regulatory path to ensure you meet compliance for ISO 13485 or ISO 9001. Pharmi Med Ltd have extensive experience of implementing Quality Management Systems whether you prefer a paper system or want to use an electronic Quality Management System (see www.greenlight.guru ). We will not just put a system in place but also ensure you receive your CE marking by our onsite services being available during the certification audit. This ensures you can have a peace of mind by concentrating on the technology to manufacture, innovate and develop the product while allowing us to manage your Quality system or if you feel confident we will set it up and hand it over to you as soon as you receive certification. The Quality Management System for Medical Devices or ISO 9001 can contain around fifty to several hundred procedures depending on the complexity of your product and process. We will also ensure all the pre-requisite documents are put in place such as the Design History File (see Design Control), the Technical File for CE marking or 510K for submission to the FDA for US markets (see regulatory services), the Design History Record and the Device Master Record.
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