Quality as a Service

Quality and compliance services for Life Sciences & Healthcare

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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

25+

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

success stories

Market-Ready Solution for Dialysis Care

Nagarro developed compliant software for a leading global healthcare company specializing in dialysis. During our nine-year-long partnership with the client, we built a market-ready compliant software product for dialysis medical devices. We integrated best-suitable practices to ensure compliance with ISO and other standards. Our solutions helped the client achieve agility, optimize costs, and enhance customer satisfaction. 

Instrument Run Management Tool

We helped a global biotech and diagnostics company revamp its R&D processes with the help of an ISO-compliant management tool with functionalities like instrument configuration management, warehouse and R&D study management, instrument test results management, and catalogue maintenance. The solution ensured better user experience, strict compliance, and multiple data science tools integrations. 

Diagnostics Instruments Connectivity Agent

Nagarro delivered a comprehensive software solution for a global BioTech and diagnostics company, integrating 200k+ IoT devices. Our solution ensured secure communication, remote access, software management, and event handling. We enhanced diagnostic instrument serviceability and achieved ISO13485:2016 compliance. 

In Vitro Diagnostic Software

Nagarro delivered full software life-cycle quality and compliance consultancy and technical documentation, including verification and validation, usability engineering, and risk management for a genomic IVD software tool of a European precision oncology company. Our contribution has been critical for compliance with the regulatory pathways to commercialise the product in Europe.

our experts

Anamaria Totan

Quality as a Service Practice Lead

Imre Csoma

Quality Management Lead

Cristian Dat

Quality Manager

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