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Quality and compliance services for Life Sciences & Healthcare

Quality and compliance of products and services are paramount in the healthcare and life sciences industry. However, maintaining compliance and sustaining quality levels while navigating an evolving regulatory and technological landscape can be a formidable challenge.
Nagarro’s Quality as a Service (QaaS) offering is a strategic enabler, providing a systematic and scalable approach to quality management in a dynamic and highly regulated environment.
We have a proven track record of delivering end-to-end digital HealthTech solutions per rigorous quality management systems requirements, seamlessly integrating good practices and standards into our every day delivery processes. 
QaaS helps healthcare and life sciences organizations tackle:
Complex and evolving regulatory landscape 


Software safety and performance, cybersecurity and data privacy issues 
Compliance risks for global operations  


The need for lean QMS processes and agile implementation of QMS changes 
Resource constraints

our achievements 

We have implemented and maintained a certified ​Life Sciences & Healthcare Quality Management System​ 



Years of experience in software development 

ISO 13485:2016


Medical devices - Quality management systems - Requirements for regulatory purposes

ISO 14971:2019


Medical devices - Application of risk management to medical devices 

IEC 62304:2006 (+ AMD 1: 2015) 


Medical device software - Software life cycle processes 

IEC 82304-1:2016   


Health software – Part 1: General requirements for product safety​ 

IEC 62366-1:2015 (+ AMD 1:2020)


Medical devices - Part 1: Application of usability engineering to medical devices

tailored QaaS services


Capacity Building 

Best suited for corporate environments
  • Quality Management System (QMS) due diligence 
  • QMS support for implementing new products or maintaining existing ones 
  • Computerized System Validation (CSV) implementation 
  • Complement inhouse QMS capacity
  • QMS support with the regulatory changes 
  • QMS processes framework and related training services 
Tailored Qaas services: Capacity Building

Knowledge Building   

Best suited for Series B HealthTech startups
  • Quality Management System due diligence 
  • Quality Management System and its processes implementation including Computerized Systems Validation 
  • Internal audits and support to external certification audits against industry standards 
  • Assistance throughout the product regulatory submission 
  • QMS processes framework and related training services


Tailored Qaas services: Knowledge Building

Services highlights    

  • E2E Project Compliance  
  • User Experience & Usability Engineering 
  • Verification & Validation  
  • Computerized System Validation 
  • QMS Consultancy & Implementation 


Tailored Qaas services: Services highlights

success stories

our experts 

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Anamaria Totan
Anamaria Totan
Quality as a Service Practice Lead
Imre Csoma
Imre Csoma
Quality Management Lead
Christan Dat
Cristian Dat
Quality Manager
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Connect with our QaaS experts