Key Solutions

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IOT

In this Digital world connected devices are becoming common-place. With businesses using legacy technologies, maintaining interoperability across numerous platforms, devices/systems is a major challenge.
Customers/Businesses need an IoT enabled strategy and connected solutions to optimally leverage IoT for creating new products.

Our Solution

Cotter technologies are having expertise for IoT consulting with roadmap your business challenges, IoT strategy and platform architecture.
Implementing IoT connected solutions on industry-leading technology platforms.

Value Add

Deeper consumer engagement with connected applications, advanced analytics solutions and insights. Rapid time to market, end-to-end IoT service management Reduced IoT testing cycle times using Virtual devices.

Data Analytics

Traditional thinking suggests that you look for expertise in your own industry or function. But as change accelerates and business models evolve, you can learn more from practices outside your comfort zone. Our data analytics services and solutions see a convergence of practices and concepts across industries.

Our Solutions

Scalable business intelligence and analytics services, Big Data & NoSQL technologies, GP-GPU, & High
*Performance Computing
*Master Big Data Management, Cloud, and Analytics as a Service and the Rise of Agile Self Service
*Data Model Disruption, ETL vs. ELT
*Collaboration and Re-Use

EU MDR remediation

EU MDR Regulation is one of the significant changes in Medical Device Industry in the last few years. It establishes more stringent requirements to ensure that products placed on the EU market won’t negatively impact human health/safety or the environment. It is mainly emphasis on Device re-classification, new Product Stewardship requirements, new labeling/IFU requirements, lot of emphasis on Post Market Surveillance, Periodic Risk management along with Use Error risk analysis, Clinical data gathering & Evaluation, SSCP, Compliance with latest standards, adequacy of design verification & validation and completion of process validation & test method validation.

Current Challenges:

Higher number of SKUs to be remediated
High cost of remediation
Lack of MDR focus due to other priorities like NPD
Lack of EU MDR SMEs to plan for EU MDR transition roadmap

Our Solutions

Strong program management with experience in EU MDR execution
Capable of performing SKU rationalization on the existing product portfolio, which reduces the cost for remediation
Highly experienced SMEs with respect to EU MDR & Tech file remediation
Availability of reusable checklist for gap assessments & remediation
Involvement of automation to reduce timelines in the areas of labeling, CER, PMS & SSCP.

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