Your Partner for
Product Design and Development Services

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Contacts

89 Rachanahalli Main road , Manyata Tech Park back side, Bangalore -560077, India.

me@kritaa.com

+91 9148595716 ; +91 8048534887

// We Serve

MEDICAL DEVICE PRODUCT DESIGN AND SERVICE

As opposed to planning and assembling all items in-house, numerous clinical item organizations go to assembling accomplices like KRITAA to speed up chance to-showcase, better oversee risk, give more noteworthy versatility, and meet maintainability targets. The ultimate objective is to further develop medical services answers for patients and specialists.
KRITAA, we give a large number of administrations, from DfX and high level assembling to robotized subassemblies and production network the executives. This guarantees obtaining the ideal parts brilliantly and value, the whole way to the completed item with high-accuracy plastic parts and bundling.

 

// we are KRITAA

We Will Help You

01
Backend Software Services

02
Frontend Software Services

03
Data Analytics Services

01
Mobile Apps Software Services

02
Custom Software Development Services

03
Cyber Security Services

Custom Software Development .

Better serve your patients and staff with optimized healthcare IT services that increase productivity and ensure all data and medical records are kept safe and secure.

Our design and development team at KRITAA medical product development through all phases – from initial concept generation through transfer to production manufacturing

Application Development Services
KRITAA
Application Development

Our Applications business is organized flat capacities. This permits us to offer an all encompassing lifecycle of frameworks coordination, counseling administrations, and a brought together way to deal with fostering the right answers for our clients' business needs.

 

 

Engineering
KRITAA
Engineering

We are one quickest developing worldwide designing administrations suppliers. From item blueprinting to help, from programming/equipment to mechanical, we work with over portion of the Research and development designing organizations across the world

 

Digital Analytics
KRITAA
Digital Analytics

Our Computerized and Investigation administrations assist plan and work with keying stage parts for our clients' Advanced Innovation Impression to control their computerized change venture.

 

IOT
KRITAA
IOT

IoT, we assist with making a completely new bundle of administrations for conveying quantifiable business results. These arrangements will play a persuasive part in making separated abilities and empower firms to arise as cutting edge undertakings

 

QUALITY ASSURANCE AND REGULATORY AFFAIRS

REGULATORY COMPLIANCE
  • Regulations/Standards gap analysis & Remediation - EU MDR/IVDR
  • RoHS/REACH/IEC/Labeling compliance
  • Biocompatibility Evaluation and Toxicological risk assessment
  • Clinical Evaluation plan and Clinical evaluation report
QUALITY MANAGEMENT SYSTEM
  • 21 CFR 820, EUMDR/IVDR, ISO 13485, compliance
  • QMS Development support
  • SOP enhancement
  • Remote audits
DESIGN QUALITY (NEW/LEGACY)
  • Develop/ update DHF
  • Technical file preparation
  • Functional / Prototype testing / Design verification & Validation
  • Usability Engineering
  • Pre compliance/Compliance testing
POST MARKET SUPPORT
  • Complaints Management/Post Market Surveillance Support
  • PSUR/PMSR
  • Risk Management documentation support
  • CER update
SUPPLIER QUALITY
  • End to End Supplier Mngt support
  • Supplier Audits and Qualifications & onboarding
  • Virtual monitoring on Investigations & CAPA closure
  • Supplier Disengagement
  • Change management

MEDICAL DEVICE ENGINEERING

NEW PRODUCT DEVELOPMENT
Software Design,, Hardware Design & Firmware Design, Mechanical Design, Industrial Design, Prototyping,
VAVE
Product Benchmarking, Reliability Improvement, Design Optimization, Obsolescence management, Cost Reduction
Application Software
Software Development & Deployment Remote Diagnostic and Servicing Manufacturing Automation Usability & Mobility Device Configuration & Programming
IOT
PACS Security HIS-LIS Integration/EMR-EHR Integration Data Analytics Device Diagnostics Connectivity Solutions and Telemedicine
V&V
Test Planning & Strategy Test Consultancy Test Design & Execution Data acquisition and Image Analysis testing Multiple device testing
Mechanical Engneering
Competitive bench marking Product design Component design Digital Manufacturing Supply chain & Logistic
// BUSINESS INDUSTRIES

Business Industries
What We Serve

Gaming & Enterteinment
Gaming & Enterteinment
Information Technology
Information Technology
Helath Care
Helath Care
Automotive
Automotive