Service offerings
KPIT provides a set of embedded software solutions that enable your medical devices to be smart and connected.

Model Based Design

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Mechatronics

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Digital Health

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Value Engineering

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Image Processing for Diagnosis

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Mechanical Design Solutions

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Quality assurance and
Regulatory affairs

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Model-Based Design
Model-based design plays a vital role in the process of an end to end product development of complex medical devices. Modeling and simulations help medical Original Equipment Manufacturers (OEMs) in terms of system optimization, and also reduce time to market. KPIT has well-proven expertise in advanced tools, domain and technology on model based engineering that can reduce system integration efforts by enhancing the performance and safety of highly complex medical devices.
Major Focus on Model-based design:
Requirements Engineering
Reliability Analysis
Functional Safety
Multi-domain System Modeling
Simulation
Software In the Loop (SIL)/Hardware In the Loop (HIL)
Virtual Prototyping
KPIT IMPACT Testing Facility
Test Method Validation
Mechatronics

KPIT's engineering approach on mechatronics service offerings describes innovative solutions for exploiting mechatronics to provide support in designing of innovative, accurate, and intelligent medical devices and optimizing conventional medical instruments.
Major focus on Mechatronics:
 
Electromechanical Design Support
Electronic Design
Motion Control solutions
Mechanical Design, Simulation, Modeling and Multiphysics Analysis
 
Digital Health
The encompassing scope of digital health such as Mobile Health Applications (apps), Health Information Technology (IT), Wearables, Tele-health and Telemedicine will reduce inefficiencies and treatment cost by improving access between doctors and patients to improve the quality of the treatment, and make medicine more personalized for patients. KPIT enables various mobile applications that are leading to rapid growth in the development of Medical Software Applications (apps). Doctors and patients are using them to monitor specific health conditions and bridge the gaps in medical care for better life.
Major focus on Digital Health:

Wearable and Sensors

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Sensor Identification, Packaging, Fusion Algorithms

Mobile Apps

Data Analytics

Connectivity Solutions

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Interfaces, Interoperability, Connector Framework

Cyber Security

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Data Integrity and Security
Value Engineering
KPIT's Value engineering services help customers develop Medical products that make best use of performance, quality and reliability while abating product and development costs, and lead time to overcome challenges. Our solutions include:
 
Value Engineering (Cost per function analysis)
Solutions for Emerging Markets
Battery Management System
Sustenance Engineering Solutions
 
Image Processing for Diagnosis
KPIT has significant experience in Image Processing techniques and applications that meet customer needs, challenges and provides an enduring bridge in the ever-expanding field of medical imaging technology. KPIT serves as an authoritative resource and self-study guide explaining sophisticated techniques of quantitative image analysis, with a focus on medical applications.
KPIT focus on Image processing for Diagnosis includes:
Identifying the unmet needs in the emerging markets in line with Biodesign process
Identifying low cost solutions for emerging markets
Build rapid and robust algorithms
Extend to map it with deep learning algorithms
Algorithm Development
Solutions to enhance clinical workflow
Check out what KPIT has to offer in the space of Life Sciences
Mechanical Design Solutions
KPIT has specialization in healthcare/medical product design services using different mechanical design and development tools. Our expertise in medical device design and Computer-Aided Drafting (CAD) drafting services of various medical products includes drug delivery devices, renal care medical devices and complex medical diagnostic systems. KPIT's proven expertise in medical mechanical engineering design support services is comprehensive for Medical Original Equipment Manufacturers OEMs to develop and design safe and efficient medical products and medical equipment. We realize the challenges of designing robust products that can be made without complicated tooling. Our experienced mechanical engineers deliver 2D CAD drafting, 3D CAD modeling, Finite Element Analysis (FEA) and Computational Fluid Dynamics (CFD) simulation services for major class II and class III medical devices like renal care, drug infusion medical devices and implants.
Medical Mechanical engineering services include:
Pre-concept
Voice of customer
Competitor analysis
Feasibility study are performed at the pre-concept stage
Concept development
Concept generation
Product styling
Human factors analysis
Look & feel design, lock-up
Usability studies
Design and development
Proof of concept
Detail design
Design for manufacturing and assembly
Tolerance analysis
COTs selection, prototyping, and reliability engineering
 
Verification and validation
Concept generation
Test plan and protocol preparation
Functional and performance testing
Environment testing
Component and material qualification
Design transfer and service manual and user manual design
End-of-life support
Engineering change management
Obsolescence management
Restriction of Hazardous Substances (RoHS) / Waste
Electrical and Electronics Equipment (WEEE) services
Legacy drawing conversion and value engineering
 
Medical-Mechanical Design and Development Services
Computer-Aided Drafting (CAD)
  • Concept design
  • Tolerance studies
  • DFMA (Design for Manufacture and Assembly)
  • New Product Design
  • Sketch based modeling
  • Feature based Parametric modeling
  • Surface modeling
  • Assemblies modeling
  • GD&T (Geometric Dimensioning and Tolerancing)
  • Part drawings
  • 2-D cross sectional layout
  • All types of conversions
  • User defined features
  • Design standardization
  • Manufacturing drawings
Computational Fluid Dynamics (CFD)
  • Flow dynamics
  • Micro fluidics
  • Coupled system simulation
  • Product analysis
  • Polymers & Metals
  • Thermal analysis inside fluid
  • Non-linear viscoplasticity
Finite Element Analysis (FEA)
  • Bio materials
  • Material Response
  • Thermal
  • Diffusion Models
  • Effects of fatigue due to pulsate loading
Modeling
  • Multiple physics/ Domain
  • Coupled System
  • Non Linear Model
  • Mechanical System
  • Fluid Modeling
Quality Assurance and Regulatory Affairs
KPIT has deep domain and industry experience in regulatory requirements and safety protocols to rapidly secure Restriction of Hazardous Substances (RoHS), Food and Drug Administration (FDA) 510(k) and European Conformity European (CE) approvals. It also has a well-established ecosystem with ISO 13485, ISO 14791 certified design house with excellent support for leading medical device manufacturers across geographies for successful regulatory submissions, validation, product design, manufacturing process and test method validation studies as per latest regulations.
Computer System Validation
Computer System Validation (CSV) for highly complex medical devices is a critical process that must be completed and documented before the medical devices hit the the market. KPIT will support medical devices manufacturers in CSV which will help to overcome the stringent Food and Drug Administration (FDA) design control regulatory requirements like 21 CFR 820.30 & 21 CFR Part 11.
Approach for CSV: (Good Practice)
Good Automated Manufacturing Practice (GAMP) 5 Approach for CSV:

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CIN: L72200PN1990PLC059594