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INTEGRATING ENGINEERING EXCELLENCE IN MEDICAL DEVICES WITH INTELLIGENT INSIGHTS

MEDICAL DEVICES AND ANALYTICAL INSTRUMENTS

 

Digitization, consumerization and changing technology landscape are challenging medical device companies to constantly innovate and use advanced technologies such as IoT, AI, and analytics to achieve real-time data gathering and generate insights to improve clinical outcomes.

Mphasis’ Medical Devices product engineering services enable organizations to develop and transform products for seamless connectivity, remote monitoring, imaging diagnostic, clinical diagnostic, and surgical applications. We also help analytical instrumentation OEMs develop data acquisition systems and enable interoperability of instruments and data systems from multiple OEMs through instrument drivers.

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SUCCESS STORIES

 

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RECOGNITION

 

OUR SOLUTIONS

 

Mphasis’ digital transformation services incorporate cloud, AI/ML, data analytics and cyber security to enable clients to deliver better business value to their end customers. With more than 20 years of experience in product engineering services in the healthcare and life sciences sphere, we provide a comprehensive set of services across the value chain.


MedTech Product Sustenance

We take end-to-end ownership of legacy products allowing our clients to focus on innovation, customer acquisition and new product development. Our robust Product Sustenance Engineering (M-PROSE) framework helps Medtech companies improve product value and reduce sustenance costs.

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Medical Device Product & Platform Development

Mphasis provides end-to-end product development services, including SAMD and SIMD solutions for diagnostics, therapeutics, and surgery. We support development for class I, II, and III devices aligned with ISO13485:2016, IEC 62304 and ISO14971 while complying with US-FDA and EU-MDR standards.

Seamless Connectivity Solutions

Using our instrument bridge layer framework, we develop instrument drivers to enable interoperability among devices and various data systems. Our services help companies comply with HIPAA, DICOM and HL7/FHIR standards to ensure the interoperability across various hospital management systems.

Product Verification and Validation(V&V)

Our NextSTEP tools and test automation frameworks help address complexity in system testing. Our services include white box, black box, API, smoke, regression, negative and compatibility testing. We also conduct compliance tests for data integrity, 21 CFR Part 11, and CSV for product deployment.

Laboratory Informatics Services

We help Pharma, CDMO, and CROs to move from paper to paperless labs through LIMS implementation and integration and EBR implementation. We provide automated computer system validations with IQ, OQ, and PQ testing solutions to comply with the GxP requirements.

Cybersecurity Services

Mphasis provides cybersecurity consulting services, risk advisory, security operation solutions, embedded devices, infrastructure, data & risk security, and vulnerability testing services for Medical Devices and Analytical Instruments industry. We comply with ISO 13485, IEC 62304, UL-2900-1, ISO 14971, NIST 800-53 and FDA, EU and MDR regulations.

Digital health technology services

Mphasis enables Digital transformation with solutions based on Cloud, AI/ML, Image Analytics, and Modernization to hyper personalize the user experience, streamline operations, lower costs, minimize risks and vulnerabilities, and accelerate innovation for better patient care.

Compliance Services

We undertake pre/post-market phase interventions for FDA compliance and MDD to MDR compliance initiatives. This includes gap assessment, document control & management, regulatory submissions, CAPA management, remediation services, device re-classification, labelling assistance, and conformity assessment in compliance with FDA, MDR, TGA and IMDRF regulatory guidelines.

THOUGHT LEADERSHIP

 

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