CRED Practical Document Writing and Management

Adapt the content to the type of report

Example: Technical file ● Identify the parts of the file – Introduction

– Description of the device – Manufacturing process – Inputs, validaiton and verification activities – Pre-clinical data – Clinical evalaution – Conclusion

● Breakdown each part in sub-part – Pre-clinical data

– Biocompatibility report – Validation of packaging – Stability study – Validation of sterilization