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MEDICAL DEVICES AND ANALYTICAL INSTRUMENTATION SERVICES

 

Co-Engineering + Life Sciences Experts = Digitally Transformed Products

INTEGRATING ENGINEERING EXCELLENCE
WITH INTELLIGENT INSIGHTS

 

With the explosion of digital transformation in the global healthcare and life sciences industry, enterprises are racing to achieve real-time data gathering through connected devices or instruments. High-quality products, innovation and effectiveness of lab equipment will be key to growth, further fueled by increasing regulatory mandates.

Specifically, the analytical instrumentation industry is driven by the need for high productivity achieved through reduced cost per sample run, and look to leverage analytics, automation and artificial intelligence to make smarter, faster and cheaper products.

Mphasis’ Medical Devices product engineering services enable organizations to develop and transform products in medical devices in the areas of monitoring, diagnostic, therapeutic, surgical and prosthetic applications. Our services also help analytical instrumentation OEMs to develop instrument data acquisition and processing systems. Mphasis also enables these OEMs to collaborate within their ecosystem through instrument drivers, and to sell their instruments and data systems to pharmaceutical companies and contract research organizations.

Mphasis’ Product Engineering Services in these domains enable solution enablement from device to cloud. Our services encompass engineering services right from concept stage through production, involving Product Strategy, Prototyping, Agile Product Development with CI/CD Build Pipeline, Verification and Validation, Test and Process Automation, Product Sustenance, Product Support, and Compliance Services.

HIGH-IMPACT, HIGH-VALUE OFFERINGS

 

Our 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 that include -

  • End-to-end product development services for Class 1, 2, 3 Medical Devices
  • Development of SAMD and SIMD solutions
  • Compliance services for FDA, MDR submissions, to enable product introduction in various geographies.

For the analytical instrumentation industry, we provide services to -

  • Develop data systems to help data acquisition from analytical instruments for Liquid Chromatography, Gas Chromatography, Mass Spectrometry and Capillary Electrophoresis.
  • Develop inter-operability instrument drivers for OEMs for various data systems thus enabling data integrity for cutting edge R&D in pharmaceutical, agriculture and food industries.

 

Instrument Bridge Layer - Third Party Instrument Drivers

Our extensive experience in developing instrument drivers enable Analytical Instrumentation OEMs to acquire and process data from analytical instruments for various Chromatography Data Systems (CDS). Some of the classes of instruments we support are as follows -

  • Liquid Chromatography (LC)
  • Gas Chromatography (GC)
  • Capillary Electrophoresis (CE)
  • Mass Spectrometry (MS)

We enable integrity of acquired data, and maintenance of audit trails, event logs and e-signatures for FDA compliance. Our architectural templates shorten release cycle for these drivers. We closely work with the OEMs to provide the driver certification or qualification for the various CDS protocols, such as Empower OIP, Chromeleon DDK.

Instrument Bridge Layer - Third Party Instrument Drivers

Medical Device Product Development

From concept to prototyping to production and sustenance, we execute product development and integration for medical devices companies. We address critical technical and design risks through prototypes early in the development cycle, and our methodologies and process are aligned to ISO13485:2016, IEC 62304, ISO14971 thereby efficiently managing risk classifications of devices, and compliance to FDA and MDR standards. This ensures our clients’ readiness for pre-market approvals and submission of their medical devices.

We also support HIPAA, DICOM and HL7 standards, thus ensuring interoperability of patient data and images across various hospital management systems.

Medical Device Product Development

THE MPHASIS VALUE PROPOSITION

 

Deep Domain Strength

 

We bring a deep understanding and knowledge of the healthcare and life sciences industry. Our team comprises of subject matter experts with core life sciences and healthcare experience who collaborate with client product managers throughout the product development cycle. We also bring in end-to-end expertise in hardware, firmware and software development on various platforms.

Niche Expertise in Analytical Instrumentation

 

We bring extensive experience with several marquee clients in development of instrument drivers for analytical instrumentation for Chromatography Data Systems (CDS).

Customer-centric State-of-the-art Labs

 

We have set up state of the art labs for our clients to enable seamless end-to-end product testing. This helps mimic validating the products in a virtual end use environment for these devices.

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SUCCESS STORIES

 

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