Services
A global Med Tech giant that manufactures ophthalmology equipment, medical lasers and a vast spectrum of solutions for neurosurgery, oncology, gynecology, and dentistry.
The client had a legacy ophthalmology MDD compliant device that needed to be transitioned from MDD standard to comply with the new EU MDR standard. The client's objective was to comply with the recent EU MDR mandate to continue to sell its ophthalmology devices in the European geography without any difficulty. To achieve this, they were looking for a trusted outsourcing partner to provide a customized compliance solution to enable seamless market access for its Class I medical device software with zero delays.
• The Mphasis team collaborated with the client RA designated person and the product team from the planning phase till the market release.
• Device Reclassification according to the Regulation 2017/745 (MDR) Annex VIII
• Impact & Gap analysis to identify additional product & software requirements based on the General Safety & Performance Requirements (GSPR)
• Risk assessment and management in line with ISO 14971:2019, to mitigate the associate hazards and ensure industry standard safety
• Changes implementation and document modification as per ISO 13485:2016, IEC 62304
• Localization of the application as required for the market registration in the target countries
• IFU, UDI and labeling implementation along with the redesign and release of new format for IFU and label.
• Modification of Conformity assessment procedures according to Annex II and III of Regulation (EU) 2017/745
• Modification of Regulatory, Clinical Strategy and Clinical Evaluation Plan.
• Creation of Post Market Surveillance Plan
• Technical File (STED) modification, obtaining QMS Certificate, and Declaration of Conformity Statement and submission to the regional market authorities
Successful acceptance for Market Registration (local bodies) to operate in 4 EU countries
Accelerated time-to-market while optimizing costs
Drove Mphasis’ program management from planning phase to market release including, tech writing support