Have your team maintain your device history file while it is being designed. Not before. Not after. MatrixALM will help you ensuring the correctness and support you creating the documents for certification.
Have processes and work instructions which are simple, efficient and easy to use and improve. Not SOPs written by someone else for someone else. MatrixQMS will help create a quality system which works for you, not against you.
Risk management needs to be integrated in the design process and the quality system. Not in some excels on some file server.
Plan and document your verification and validation activities while you design your device.