Full Technical Documentation

Full package of Technical Documentation is included all templates that required for Compliance with EU MDR 2017/745. Each template is included required sections, requirements, information of how to complete the template as per requirements and 1 example for better understanding the requirements and filling up the template. This package is included:

- Product Description and technical documentation content

- GSPR Checklist (as per Annex I MDR)

- Usability Engineering (as per IEC 62366-1 / EN 62366-1)

- Risk Management (Plan & Report) as per ISO 14971

- Clinical Evaluation (Plan & Report)

- Software Validation (Plan & Report) as per IEC 62304

- Sterilization validation (Plan & Report)

- Design and manufacturing of product

- Label and IFU

- EU Declaration of Conformity

- Biological Evaluation (Biocompatibility) as per ISO 10993 series

- Pre-clinical study report

- Post marker Surveillance Plan (PMS) and PSUR

- Stability Study

- Etc.