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.