Validation of a process demonstrates that, when a process operates within defined limits, it will consistently produce product complying with predetermined requirements. It is part of the integrated requirements of a quality management system (ISO 13485), including design and development control, quality assurance, process control, and corrective and preventive action.

MDProject can support you with identifying the requirements for validation specific to your medical device and related processes, and develop validation study strategies and schemes.

Validation activity examples:

– Biocompatibility
– Clean room
– Product and process
– Software
– Packaging, labeling
– Sterilization
– Shelf-life stability
– Clinical

MDProject can assist you in writing validation master plans, validation protocols and reports but also provide “hands on” activities regarding these topics. Furthermore, we can assist you in sourcing test facilities and advise you in re-validation activities.