#FutureReadyHealthcare
Indegene unlocks 20- 30% productivity enhancement in EU-MDR compliance, for a leading device manufacturer
The Customer
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.
The Challenge
The customer faced a significant challenge in aligning their operations with the European Medical Device Regulation (EU-MDR), a comprehensive regulatory framework that demands strict adherence to quality and safety standards. The requirements laid out demanded a thorough understanding and alignment of technical documentation, requiring substantial updates and revisions.
External support becomes essential to augment the existing team or provide specialized expertise and adhere to the specified deadlines.
The Need: 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, the customer required support to review the remediated documents against EU MDR compliance requirements and draft the final product technical file for regulatory submission to their Notified Body before stipulated timelines.
The Solution
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.
Outcomes
The comprehensive review ensured 100% compliance with the latest regulations. Through this partnership with Indegene, the customer was able to not only meet their recertification deadline but also witness an increase in productivity.
100%
Quality, compliance, and timelines
90%
First draft acceptance
20-30%
Productivity enhancement
Ready to enhance compliance efficiency? Contact us now to explore innovative solutions tailored to your unique needs.