What are some common practices in documenting design changes of class III products (assuming these are design changes: change of primary sterile packaging material or design, new size or shape of an existing device with same intended use, extending the indications for use based on new data etc)?
Which documents need revision for such changes?
Are design reviews mandatory for changes?
When should one create new DHF?
Which documents need revision for such changes?
Are design reviews mandatory for changes?
When should one create new DHF?