A renowned medical technology company that produces a wide range of medical devices, including cardiovascular, diabetes care, and neuromodulation devices. The customer was exploring collaboration with external partners to support Technical Documentation compilation for EU-MDR Compliance.
Requirement of a skilled regulatory team to support and compile product technical documentation of a complex product comprising of 250+ supporting documents
Further to EU MDR gap assessment and remediation of 250+ documents at the client end, client required support to review the remediated documents against EU MDR requirements and draft the final product technical file for regulatory submission to their NB before stipulated timelines.
Indegene established a dedicated team of highly skilled regulatory affairs professionals with deep domain knowledge in EU MDD/MDR requirements to partner with the client for given scope of the project.
Indegene’s state of the art GSPR template and well defined projection execution plan paved way for a smooth compilation process.
The technical file was compiled and documented in line with the EU MDR Annex II requirements.
Indegene conducted detailed and thorough review of the technical documents to ensure compliance with the applicable latest version of standards/regulations.
Indegene also drafted the General Safety Performance Requirements (GSPR), Declaration of Conformity (DoC), and the Device risk classification documents as part of the Technical file compilation.
Indegene consolidated the technical information required for EUMDR submission per the Notified Body (N.B) preferred route for submission.
By partnering with Indegene, the client was able to complete their technical file documentation well in advance of their recertification deadline.
Quality, compliance, and timelines
First draft acceptance