MakroCare can make sure you are fully equipped and in compliance with the new EU MDR regulations.
MakroCare’s team is expert on how the new EU MDR regulations will change current medical device processes and requirements. From structuring a clear timeline to conducting a strategic gap analysis to providing EU MDR training for continuous progress, we ensure your implementation process will meet the deadline with the specialties necessary to accurately advise the transition.
Till date, we supported over 700 products in transition from MDD to MDR in last 3 years.
those found to present a safety risk
Regulatory strategyBuilding up an ideal Regulatory strategy depending on the device for you to effectively get a handle on EU MDR aspects including Technical, Quality, Clinical, Post-Marketing, Labeling, Economic Operators and other areas
GAP AnalysisMakroCare reviews Tech files & data to find the gaps in EU MDR compliance and provide a remediation plan to address those gaps
Clinical EvidenceFull service clinical evidence programs from advisory to implementation involving Retrospective/ EMR data, Surveys, Literature and setup of Registries. Review your device data, determine usability & final report generation
Post Market Support ActivitiesSupport PMS along with PMCF formalizing a plan for aggregate reports by process creation to standardization of templates/SOPs. Also Support in PSUR, SSCP and annual updates
UDI SetupMakroCare advice in setting up UDI program along with required software
Vigilance & Safety ReportingMakroCare supports with reporting incidents, complaints and safety in the US, Europe and other markets
LabelingAs every label needs to change, we can assist in reworking on your IFUs and corresponding artwork (labels) accordingly.
Technical AssistanceOur Technical team helps in Biocompatibility , Risk management documents, and Usability Study/Reports. We can provide custom model to fit offsite or onsite resources to work on this interactively.
Achieving your EU MDR certification requires a clear strategy, partnering with a notified body, compliance with new regulations – and a lot of documentation. That’s why MakroCare offers independent quality control checks of your EU MDR application to ensure that there are no administrative, clinical, or technical gaps that can derail your certification. And if your notified body does send you notice of non-conformities, we can help you draft a compliant response outlining the planned mitigation for each one.
Let's talk about how MakroCare can help you
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