If you are looking for an effective way to monitor and manage the activities of your company, the best solution is to create and / or implement a Quality Management System. This will allow you to provide products and / or services that meet the needs of your customers, address the risks and opportunities associated with the context of your business and demonstrate that the processes meet the established requirements.
The use of internationally recognized standards such as ISO 9001 and ISO 13485 is a solid starting point for achieving your goals. In particular, ISO 13485 is a harmonized technical standard for quality systems issued specifically for companies involved in the production, storage and distribution of medical devices.
The application of this standard is voluntary for producers wishing to sell their devices in Europe, but almost all companies choose to apply it because, generally, it meets the requirements of the regulations and is considered suitable for the application of harmonized technical standards. In addition, it meets the system requirements required in many other countries such as Canada, Japan, Australia and many others.