Regulatory Compliance Support Services

Medical device companies are quickly embracing the new normal by adapting to the rapid market changes. The key drivers for growth today are regulatory compliance, faster deployment cycles and higher operational efficiency.

The ever-evolving and stringent regulatory timelines for compliance within 2020 (MDR) and 2022 (IVDR) are prompting medical device manufacturers to perform new conformity assessments in sync with the dynamic rules. Significant changes in the European Union regulations, replacing directives to regulations viz. MDR and in-vitro device regulation (IVDR) and the mandatory unique device identification (UDI) requirements are urging Original Equipment Manufacturers (OEM) at large to focus more on portfolio rationalization and harmonizing QMS.

Our streamlined compliance processes empower medical device manufacturers and OEMs to reduce workarounds by deploying comprehensive engineering support in areas like pre-clinical validation, regulatory compliance, cybersecurity & privacy, quality systems & processes, product certifications & compliance also product safety & usability.

Our product development services are focused around:

Regulatory Planning

Our expertise in identifying applicable harmonized standards, common standards and compliance testing standards helps derive a perfect impact assessment plan.

Impact Assessment & Gap Analysis

With assessment criteria selection including assessment for FDA, device classification, portfolio impact assessment and so on, we help you overcome the flaws and gaps while maintaining the overall objectives of legal framework for compliance.

Regulatory Remediation

Expert regulatory remediation assistance for regulatory requirements consolidation and tech documentation creation, realignments, rewrites and reviews helps you to execute the correct compliance remediation.

Safety and Compliance Test

QuEST assures integrated, strong and safe compliance tests with labs to facilitate tests like compliance with IEC 60601x, pre-compliance testing (electrical), and EMI / EMC for products to help deliver highly efficient solutions.

Post-Market Support

We offer technical documentation relevant for post-market requirements, benefit-risk determination, labelling, CAPA support, field safety and corrective actions, and product recall management solutions for OEMs as 360-degree support process.

QuEST collaborates with its clients for mapping your work-streams and performing do-buy analysis, and eventually creating a strategic partnership roadmap. We build Centers of Competencies (CoC) to drive successful engineering solutions for your device development workflows. Our constant endeavor is to:

Minimize product development costs and time to market
Innovate workflows and IT infrastructure with an all-inclusive multidisciplinary approach
Integrate your products with latest technology standards, platforms and devices, to boost interoperability, connectivity and customizability

Doctors are very interested in the new features provided by us. Thank you for your diligence and hard work.

Global Medical Devices Manufacturer

QuEST’s expertise in medical devices and capabilities in providing high quality deliverables in a short time is really impressive.

Leading Medical Devices OEM

Transmission & Distribution

Software Engineering

Since 2004, 500+ Man-years
Development & Sustenance of NMS, DMS suites
Real-time data (PMU) based situation awareness
Next generation product development

Mechanical Engineering

Transformers, Switchgears, Protection Relays, Power Electronics, Drives and Motors
DAQ (RTU,BCU)

Embedded Systems
DAQ, IEDs, Protocols

Generation

Mechanical Engineering Services

Since 1997, 1000+ Man-years
Thermal/Fossil (GT, ST, Boiler, GN, BoP)
Renewables (Wind, Solar, Hydro)
Distributed Power – Aero derivative products

Software Engineering

Since 1995, 500+ Man-years
Monitoring & Control Solutions (DCS, SCADA) and Remote Monitoring

Embedded Systems

RTUs, IO Cards, Protocols

System Engineering

I&C detailed engg, control loops, wiring, components, control panel layouts
System integration and testing, FAT, SAT

Substation Automation System

Software Engineering

Since 2007, 300+ man-years
SAS development & sustenance
Testing, Test automation and release management
IEC61850 Expertise
Engineering Tools & Frameworks
Cyber Security

Embedded Systems
IEDs, Protocols

Smart Grid

Remote Monitoring

DER integration & VPP

Collaborative DR

Embedded Systems

Smart meter design, firmware and protocols

Supply Chain Management

Maximize Your Supply Chain Performance

Today’s supply chain networks are more complex than ever. QuEST helps OEMs to solve this challenge by monitoring and managing the existing processes more efficiently, and by making fundamental improvements in the way your supply chain is organized. We can also help you launch new products successfully by establishing supplier networks and transitioning parts from development into production. We deliver the skills to handle the complete lifecycle and coordinate the work at every step in the process.

Our services include: Supply Chain Visibility, Supplier Rationalization, New Product Launch and Product Transition, Supplier Readiness and Producibility, Product Cost Reduction and Asset Tracking.

Remote Monitoring

Remote Monitoring of Solar Photovoltaic (PV) Plant

Scope:

The customer wanted to introduce a scalable, secure, customizable, and cost-effective remote monitoring solution, and also to develop a platform that can monitor, manage and forecast power generation to help meet supply commitments to Utilities.

Solution:

Customized EAGLE Framework – Solution accelerator for local and remote monitoring
Build Solar Photovoltaic (PV) specific computation engine
Integrate 1 PLC and 2 Modbus gateways that collects data from field devices (~2000 IO points)
Integrate systems specific to PV like weather stations, pyranometer, etc.
Integrate third-party AC and DC side equipment like invertors and transformers.
Implement automated as well as manual control features for periphery lightings and exhaust fans
Implement remote monitoring of the plant from customer headquarters

Results:

Highly modular, scalable and customizable platform for remote visualization and control
Built-in capabilities like geospatial information, remote data acquisition, reporting and highly customizable user interface
Uses industry standard technologies like OPC UA for secure and reliable data transfer over the internet
Supports a wide range of industrial protocols
Offers powerful and intuitive user interface building capabilities with scripting support

Distributed Control System

Japanese OEM saves 6,000 Man-Months

Scope:

A Japanese multinational OEM formed a long-term partnership with QuEST to design and develop a customized distributed control system. The next-generation system runs on client-server architecture and integrates with database systems, mobile apps, and cloud apps.

Solution:

Ideation, design, development, and testing
Deployment support
Product sustenance and enhancement
Migration and porting
Cloud and mobility enhancements

Results:

OEM has deployed QuEST’s distributed control system for more than 100 thermal power plants across the globe
OEM saved 6,000 months of engineering resource time, which generated significant savings

Onshore Wind Cost Out

Leading wind turbine OEM saves $11 Mn with Managed Services

Scope:

Identify opportunities to reduce component and development process costs for one of the world’s leading wind turbine OEMs. Evaluate processes for conceptual or detail design, design evaluation and verification, sourcing negotiations, and best-cost country selection.

Solution:

Provided multi-faceted, cross-functional team, including wind turbine experts
Recommended cost-savings across the product development lifecycle
Ensured designs with cost saving measures, met performance requirements
Identified redundancies to be eliminated in materials, processes, labor, inspection, packaging, and logistics
Explored best-cost country manufacturers and suppliers to reduce costs

Results:

$11 million savings in product development cost, realized through design changes and best-cost country sourcing
Streamlined solution implementation, reducing drag on internal resources

Engineering Analytics

Leading Power equipment manufacturer reduces unplanned expenditure by 25%

Scope:

A leading Power manufacturer wanted to increase the availability of turbines through mechanisms that can avoid damage and hence reduce unplanned expenditure. They partnered with QuEST to develop a tool that can also make the data spread across multiple silos, help in rapid data mining, and give a consolidated view to monitor performances.

Approach:

Review of performance and alarm data from different power plants
Develop algorithm to monitor performance parameters
Implement fuzzy and statistical methodologies combined with data mining techniques to predict failure
Display the output in various user-friendly formats

Result:
Technical

Reduced labour-intensive data mining effort by integrating data from multiple databases
Low-cost/rapid software development process
Packaging tool for easy-to-use application

Business

Timely and accurate assessment of gas turbine component health during operation avoids damage
Increased availability by 30%
Reduced unplanned expenditure by 25%

Mechanical Design and Simulation

US OEM cuts BTU Costs by 50% with Propane Fuel System Design

Scope:

US-based OEM partnered with QuEST to develop a fuel system to support burning liquefied propane and heavy gas fuel during start-up, runtime and shut-down.

Approach:

QuEST designed the gas system based on flow parameters and component selection with fuel variants.
Key components include heat-tracing and blanketing systems to maintain fuel temperature and a compressor discharge pressure (CDP) bleed-piping system.
QuEST also developed field modification instructions and a mechanical design package that includes CAD models, engineering drawings, material data, interface details, and vendor part specifications.
To ensure system performance, QuEST conducted pipe stress analysis and computational fluid dynamics (CFD) flow analysis and confirmed that the system adheres to Power industry regulations.

Results:

50% reduction in cost per BTU
Avoids overspend shutdowns
Accommodates unit design variations and allows for retrofitting

Digital Transformation

US Museum reduces Gas and Electricity Consumption by 15%

Scope:

Reduce energy use for a major US museum by implementing an energy efficient temperature and humidity control solution integrated with the museum’s HVAC system.

Approach:

Optimized energy consumption by leveraging an IoT network to access 1.3TB of historical data. Applied Machine Learning algorithms to predict optimal set points for dehumidification, reheating and re-humidification.

Results:

15% reduction in electricity and gas consumption
Savings from lower usage of natural gas was $70,000 per year
Savings from lower consumption of electricity was $280,000 per year

Aftermarket Services

End-to-End Aftermarket Capabilities

QuEST offers a wide range of fully managed aftermarket services supported by a dedicated CoE for each customer. Our unique combination of local-global resources provides the expertise Power companies need to execute aftermarket services efficiently, and to keep power systems operating at optimum capacity.

Our services include: Modifications and Upgrades, Outage and Repair Tool Engineering, Product Fleet Data Management, Repair Engineering, Nonconformance Engineering, Technical Publication Services, Spares and Service Part Management, Remote Monitoring and Diagnostics

Control Systems Engineering

Accelerated and Cost-effective Execution of Control System Engineering for New and Retrofit Projects

QuEST provides a range of control systems engineering services that span hardware engineering, software engineering, testing, and commissioning support to help OEMs, Utility companies, and EPCs to design and deploy new control systems and retrofit existing systems. Our services help Power companies to complete projects cost-effectively and provide global support in the Power market to meet the increasing demand for traditional and renewable forms of energy.

Our services include: System Configuration and I/O Engineering, Control Logic Implementation, HMI and SCADA Configuration, System Testing and Commissioning

Digital Transformation

Automate and Optimize Power Network Generation, Transmission, Distribution and Consumption

QuEST’s digital transformation solutions enhance the real-time capabilities of a wide range of Power company processes:

Asset planning and performance management
Operations and field support
Energy aggregation, management and storage integration platforms
Supply and demand platforms
Network controls
Connected and interoperable devices
Digital customer models
Smart sensors for homes, cars, cities, and wearables.

Our services include: Artificial Intelligence, Enterprise Applications, Internet of Things (IoT), Virtual Reality/Augmented Reality, Robotics R&D and Security.

Engineering Analytics

Actionable Insights to drive Digital Transformation of Power-system Engineering Processes

For OEMs and Utilities that need to optimize power generation, transmission, distribution, and consumption, QuEST provides the expertise to mine and analyze data from disparate systems. We leverage technology to cleanse and process data, and then produce data models to analyze the data and generate predictive analytic reports. With this information, Power companies can effectively analyze operational data in real-time to improve process efficiencies as well as system reliability and availability.

Our services include: Prognostics and Diagnostics, Energy Management and Power Utilization, Transmission and Distribution (System Reliability and Consumption Analytics) and Data Analytics for Actionable Insights

Manufacturing Engineering

Modernize Engineering Processes to Accelerate System Delivery and Repairs While Lowering Production Costs

QuEST’s Manufacturing Engineering solutions feature quick turnaround times and detailed processes based on approved Power industry standards. We have built clear documentation on how to apply process improvements, so power companies can improve margins by optimizing manufacturing costs and enhancing product quality.

Our services include: Parts Production Engineering, Supply Chain Management, Aftermarket Support, Manufacturing Process and Inspection Optimization, and Technology Transformation.

Mechanical Design and Simulation

The Expertise to Support Unique OEM Workflows and Drive Products to Market Faster

QuEST provides mechanical design and simulation to support a wide range of power generation systems: gas turbines, steam turbines, generators, internal turbines, skids, enclosures and structures, as well as renewable energy systems for onshore and offshore wind power generation.

Our services include: New Product Development, Sustenance Engineering, Product Fulfilment, Product Cost-Out, Configuration and Engineering Change Management, and Piping Engineering Support

Software and Electronics Product Engineering

Drive New Product Development and Sustain Existing Systems

QuEST offers a wide range of software and electronic engineering services that help to drive new system design and development, and to enhance and sustain the lifecycle of existing systems. For every solution we deliver, we apply an extensive verification and validation process to ensure best performance.

Our software engineering services include: New Product Initiatives, Legacy Product Enhancement and Sustenance, Testing and Test Automation, Continuous Integration and DevOps.

Our electronics engineering services include: New Product Initiatives, Legacy Product Re-engineering and Obsolescence Management, Validation and Verification, and Certification Support Services