Product Dossier

Preparing a technical design/dossier for medical devices, in accordance with:

    • MDR 2017/745 to obtain the CE marking.
    • FDA: Premarket Notification submission 510(k) and/or Premarket Approval Application (PMA).
    • Requirements of different markets: LATAM, China, India.

Reviewing/adapting the TF:

    • Reviewing the existing technical file and its associated annexes, contacting owner company to address shortcomings and adapting to regulatory requirements.


    • Registering the responsible person(s) for medical devices (RPS).
    • Marketing communications for and/or commissioning medical devices (CCPS).
    • Communications regarding the distribution of medical devices
    • Data entry management in EUDAMED: SRN, UDI, etc.
    • Communications and data entry in databases of each country.

Compiling and assessing documentation for the file:

    • Descriptive documentation.
    • Classification review.
    • Declaration of conformity, CE marking.
    • Analyzing/documenting block diagrams, schematics, drawings, flow charts, etc. of the product and the necessary explanations to understand them.
    • Analyzing manufacturing method documentation:

– Flow chart of manufacturing processes, manufacturing facilities, machinery and tools.
– Written procedures. Work instructions.
– Road map/process sheets. Inspection and test records. Batch file.

    • Reviewing product verification documentation, biocompatibility.
    • Reviewing functionality documentation: usage reports, clinical evaluation, clinical literature.
    • Cleaning requirements and microbiological controls. Cleaning and sterilization processes.
    • Instructions for use, installation and maintenance. Labeling. Use of graphic symbols.
    • Preparing/reviewing the process validation procedure.
    • Reviewing the tests performed. Applicable and applied regulations.
    • Reviewing in-process and final product testing.
    • Risk analysis advice/review. Risk Management.
    • Preparing/reviewing essential requirements analysis.
    • Post-marketing monitoring.