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Design quality for the remediation of technical files according to (EU) 2017/745 and ISO 13485

Project duration: 2 years

Brief description

In order to ensure the continued market approval of existing products, the technical files are reviewed and, where necessary, remediated and supplemented to establish conformity with the Medical Device Regulation (MDR, (EU) 2017/745). As part of design quality engineering, PTA supports in particular quality management within the framework of ISO/EN 13485 to ensure quality, safety, usability and performance of the product design. As part of the remediation of the technical documentation, the technical design documentation is inspected for conformity with the MDR and the design control process. First and foremost, existing information is restructured and, if gaps are discovered, rework is commissioned in the development or testing department.


The customer is internationally operating in the fields of medical vacuum technology and obstetrics.

Subject description

The assessment of technical documentation includes documentation from all areas of the design control process as well as the post market phase: Risk management documentation according to ISO 14971, manufacturing and design of medical devices according to ISO 13485 (requirements management and product design documentation (mechanical, electronic, software documentation), verification and validation documentation), usability engineering documentation according to ISO 62366, post-market surveillance documentation, clinical documentation (CER, PMCF), safety-relevant contents of the accompanying documentation (instructions for use, product label).


Project period01.01.2022 - 31.12.2023

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