The challenge: a start-up in the field of 3D printing was in the technical and industrial development phase for its first medical device. This company wanted to start collecting clinical cases very quickly on the one hand and was looking for funding for their innovative project on the other. This start-up did not have in-house expert resources in regulatory affairs, quality and clinical affairs.
Analysis and strategic approach: OHC first considered the urgency of the request. The collection of clinical cases being fundamental according to the company’s strategy, OHC used the specific regulatory context (transition period of Directive 93/42/EEC and the regulation (EU) 2017/745 (MDR)) to carry out a short-term compliance plan.
OHC also considered the typology of the team and carried out a compliance diagnosis to perform a gap analysis and remedy the lack of formalization regarding the design and manufacturing data.
Finally, OHC identified the need for writing a formalized state of the art justifying the innovative nature of the system to help the company compile its funding application files.
Results: OHC produced a comprehensive technical documentation covering risk analysis, production data and solutions for compliance with safety and performance requirements. OHC also gave recommendations for good practices in compliance, correction, and formalization.
To anticipate medium-term changes, OHC also provided a strategic regulatory compliance plan for the MDR.
The rational relating to the state of the art written by OHC and integrating:
- Research and critical analysis of literature data,
- A discussion on the justification of the innovative approach,
- The design philosophy deployed to meet identified clinical needs,
Participated in obtaining financing to allow the company to continue its development.