EU MDR Product Files:

Summary:

Challenge: A small medium-sized MedTech company faced the challenge of preparing technical documentation for its products within a tight timeframe and submitting them to the notified body. The company also needed to assess feedback on previously submitted files, develop corrective actions, and incorporate these into subsequent documentation.

Results:

• Feedback from the notified body was reviewed and evaluated.
• Technical files were assessed, weaknesses identified, and improvement measures defined.
• Implementation of improvements was carried out and supported.
• Know-how and practical knowledge were transferred to the company’s employees.

This enabled the client’s staff to focus on specific tasks and reduced the need for extensive corrections.

Client Profile: The company is a small to medium-sized MedTech enterprise based in Germany. It manufactures and distributes non-active medical devices in the fields of urology, gastroenterology, anesthesia, and ventilation, both for large, globally operating MedTech corporations and through direct distribution to dealers.

Problem: The MedTech company was confronted with a short-notice change of its notified body, resulting in a compressed timeline for the submission of technical documentation. Human resources were insufficient due to staff turnover and a lack of knowledge transfer, leading to a diminished knowledge base in critical areas. Additionally, the technical documents were prepared with a narrow internal view of the regulatory requirements. Feedback from the newly appointed notified body on the initial submissions revealed the need for external support.

Solution: StingOrg supported the MedTech company with extensive expertise in its products and best practices in quality management (QM) and regulatory affairs (RA), which included:

• Analysis of notified body feedback: Identification of non-compliant documents and development of appropriate solutions.
• Evaluation of other QMS and technical documents: Assessment of systemic conditions and practical implementation, with further suggestions for document optimization.
• Staffing support: StingOrg took over the revision and creation of parts of the technical documentation.
• Training and knowledge transfer: General training and education of the team on common documentation practices.

A StingOrg consultant worked on this project together with the RA team, which was primarily responsible for the preparation and compilation of the technical documentation.

Results: The following results were achieved:

• The technical files were submitted within the scheduled timeframe.
• The related documents were brought up to an improved standard.
• Extensive knowledge and expertise were transferred into the organization.
• The company independently adapted processes based on the improved technical files, resulting in an overall improvement of the situation.

Conclusion: Through strategic collaboration with StingOrg, the MedTech company transformed its practices for managing technical documentation. By redefining standardized documentation content and associated processes and investing in resources, the company not only achieved compliance with regulatory requirements for technical files but also gained additional know-how. Operational efficiency in submitting technical documentation improved.

This case study highlights the importance of active knowledge management and the value of a competent external perspective on documents and processes.

Compared to larger companies in the MedTech sector, smaller firms face particular challenges in attracting and retaining employees with industry-specific knowledge and expertise. A strategy to reduce so-called “brain drain” includes careful employee selection, effective knowledge transfer, and maintaining a positive working environment. The company in this case serves as a model in this regard. Nevertheless, the departure of key employees cannot be completely avoided. In such cases, external support—such as that provided by StingOrg—can be a highly effective solution.