The company obtained CE marking in less time thanks to Rephine’s global approach to ensure not only the development and validation of the software but also the necessary quality assurance system (QMS).
About this Case Study
The case study involved CE Mark for a new Medical Device Software. The company has developed software that is considered as a Medical Device. They must comply with the regulatory requirements and obtain the CE Mark for the
commercialisation of the new product in Europe.
To learn more about the successful project and the comprehensive results achieved in obtaining CE Mark compliance, download the full case study now.
Discover the step-by-step process, key improvements, and valuable insights that led to the company obtaining CE mark in a shorter time period.
Download the Case Study
View other our other resources and company news
Article Maintaining Data Integrity with Digital Validation
Blog Shaping the Future of Femtech to Inspire Inclusion and Innovation
Article 3PARL® Consortium grows stronger with Qualandre’s emphasis on ethical conduct and trustworthiness
Blog Innovative Solutions for Cancer Diagnosis and Prevention
Article Owlpharma joins 3PARL® to propel mission for ethical GMP supply chains in Life Sciences
GxP Consultancy Decoding the technological minefield – A tactical approach to maximising Life Sciences R&D Software implementations
Blog All change for computer software assurance in Life Sciences
Article Pharma Audit among newest members of the recently launched initiative 3PARL®
Blog