This project aims to support the cultural and operational transition of a plastic component manufacturer to life science standards. The intervention focuses on regulatory strategy, quality support and the optimization of submissions to health authorities in the United States and the EU.
2021 - Ongoing
France
Health and life science
To position itself as a leader in the life sciences sector, the company must make a strategic shift by adopting robust quality and regulatory practices, which are very different from the previous methods applied to plastic components. The EU MDR directive and the requirements of authorities such as the FDA require a thorough review of internal practices.
The project consists in supporting the marketing, R&D and QA teams by providing a regulatory strategy adapted to the American and European markets. It includes the drafting and revision of documents in accordance with the requirements (21CFR820, ISO 13485), the training of teams, as well as the preparation and support during audits and regulatory submissions. The approach aims to build solid technical files and to improve the added value of the services offered to customers, thus ensuring a harmonious transition and better responsiveness to the requirements of health authorities.
The client expects expertise in regulatory affairs capable of leading the transformation of internal practices towards life science standards. He is looking for comprehensive support to structure the regulatory strategy, optimize submissions and strengthen compliance with health authority requirements. The challenge is to facilitate the transition, to improve the value provided to customers and to guarantee continuous support for the preparation of audits and the assembly of robust technical files.
Transforming quality practices into life science standards.
Optimize submission processes to health authorities.
Ensure comprehensive support in training and audit support.
The mission is based on global support in regulatory affairs in order to transform the manufacturer's quality management. It includes defining an appropriate regulatory strategy, drafting normative documents, training teams and preparing for audits. The aim is to enable teams to develop proprietary devices that comply with international requirements and improve submission processes to health authorities, while strengthening partnerships with customers.
Develop a regulatory strategy for the US and EU markets.
Write and review documents according to FDA and ISO 13485 standards.
Train and support teams during regulatory audits and submissions.
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