Coray is the Director of GSI Partner Marketing at PTC, based in London, UK. She has led Analyst Relations and Corporate Communications within PTC’s marketing organization. Prior to PTC, Coray ran Industry Relations at CRM startup Creatio, overseeing investor, analyst, and PR engagement. She began her career in financial services as an equity sales trader at Needham & Co. in New York, covering Industrials, including PTC, from an investment perspective.
MedTech Innovation Requires More Than Compliance
Medical devices are becoming increasingly connected, software-driven, and complex. As innovation accelerates, MedTech manufacturers face growing pressure to deliver products faster while maintaining quality, ensuring security, safety, and meeting evolving regulatory expectations.
Yet many organizations continue to rely on disconnected systems, spreadsheets, manual processes, and legacy application lifecycle management (ALM) tools. Requirements, risks, tests, quality records, and release evidence often live in separate environments, making traceability difficult to establish and even harder to maintain.
The result is fragmented visibility, increased compliance risk, lengthy audit preparation cycles, and significant manual effort across engineering, quality, and regulatory teams. As product complexity continues to grow, MedTech leaders need a more connected approach to product development. They need a complete digital thread that enables traceability across the entire lifecycle.
Introducing Trace360 MedTech
Trace360 MedTech is a joint solution from Tata Consultancy Services (TCS) and PTC designed to help MedTech manufacturers establish complete product traceability from requirements to patient impact.
Combining PTC Codebeamer with TCS advisory services, implementation expertise, migration accelerators, organizational change management, and a purpose-built MedTech Solution Template, Trace360 MedTech creates a connected and scalable foundation for modern product development.
The solution enables organizations to connect:
- Requirements
- Risks
- Verification and validation activities
- Test management
- Defects and issues
- Change control processes
- Audit trails and reporting
- Quality and compliance activities
- Release readiness evidence
- Downstream product and ecosystem information
Through these connected relationships, organizations gain complete visibility across the product lifecycle while improving collaboration among engineering, quality, regulatory, and product teams.
The result is stronger governance, faster decision-making, improved compliance readiness, and greater confidence in product quality and patient outcomes.
Connect product decisions to patient outcomes
Gain complete traceability across requirements, risk, testing, quality, and compliance.
Explore PTC’s MedTech Solutions
Traceability that drives better patient outcomes
Traceability that drives better patient outcomes
Traceability that drives better patient outcomes
Traceability that drives better patient outcomes
Traceability that drives better patient outcomes
Traceability that drives better patient outcomes
Traceability that drives better patient outcomes
Traceability that drives better patient outcomes
Traceability that drives better patient outcomes
"For MedTech organizations, traceability is no longer simply a compliance requirement. It's the foundation for connecting innovation, quality, and patient outcomes. By establishing a complete digital thread across requirements, risk, testing, and quality processes, organizations can accelerate development, improve audit readiness, and deliver safer products with greater confidence."
Why Product Traceability Matters More Than Ever
Today's MedTech products generate enormous volumes of data throughout development. Requirements evolve. Risks change. Software grows increasingly sophisticated. Testing expands. Regulatory scrutiny increases.
Without a connected digital thread, organizations struggle to answer critical questions:
- Have all requirements been verified and validated?
- Can we demonstrate complete risk coverage?
- What downstream systems and teams are affected by a change?
- Is audit evidence readily available?
- Are we prepared for release with confidence?
When traceability is maintained manually across disconnected systems, answering these questions becomes time-consuming and introduces unnecessary risk.
Trace360 MedTech helps eliminate these challenges by establishing trusted relationships across every critical product artifact, creating continuous visibility into development progress, quality status, compliance readiness, and release preparedness.
A Structured Approach to ALM Modernization
Modernizing ALM requires far more than implementing a new technology platform. Organizations must migrate legacy data, align processes, integrate systems, establish governance, and successfully drive adoption across multiple teams and functions
Assess & Advise
Evaluate the current ALM landscape, development processes, regulatory requirements, tool environments, and modernization priorities.
Migrate & Modernize
Accelerate migration from legacy ALM and requirements management solutions using TCS Pravaas migration accelerators and proven modernization methodologies.
Connect the Digital Thread
Establish traceability across requirements, risks, tests, defects, approvals, baselines, release evidence, and broader ecosystem integrations, including PLM-connected processes.
Configure for MedTech
Align workflows, controls, governance models, and reporting structures to support MedTech-specific development, quality, and regulatory requirements.
Drive Adoption
Enable lasting transformation through organizational change management, training, governance frameworks, and stakeholder engagement.
Scale Across the Enterprise
Expand capabilities across product lines, business units, development teams, and global operations.
Bringing Together Transformation Expertise and ALM Leadership
Trace360 MedTech combines the strengths of both organizations to help manufacturers accelerate modernization while reducing risk.
TCS contributes:
- MedTech Solution Template
- Pravaas data migration accelerator
- MedTech domain expertise
- Advisory and target operating model design
- Organizational change management
- Ecosystem collaboration capabilities
- GxP validation expertise
- Global delivery and implementation services
- Configuration best practices and process engineering expertise
PTC contributes:
- Codebeamer, an ALM platform purpose-built for complex regulated development
- Requirements management
- Risk traceability
- Verification and validation management
- Test management
- Defect tracking
- Workflow governance
- Audit trails and reporting
- Release readiness management
- End-to-end lifecycle traceability
Together, TCS and PTC provide a scalable foundation for complete product traceability across the MedTech product lifecycle. [Trace360 M...M Solution | PowerPoint]
Empowering customers with industry specific tools and business solutions
Empowering customers with industry specific tools and business solutions
The TCS MedTech solution template provides preconfigured processes and a data model covering Requirements Management, Test Management, Risk Management, and FMEA. It enables end-to-end traceability across the V-model by linking requirements, risks, tests, and compliance artifacts to support complete product lifecycle visibility. Built-in automation capabilities, such as risk calculations, FMEA assessments, risk profiling, and DHF generation, help customers accelerate implementation. Integrated AI agents further enable business users to perform their daily activities more efficiently.
Modernize ALM for Faster, Safer MedTech Innovation
Discover how ALM, AI, advanced vision technologies, and connected lifecycle management are helping MedTech organizations accelerate innovation and improve patient outcomes.
Explore AI in MedTechWhat Customers Can Achieve with Trace360 MedTech
Organizations adopting Trace360 MedTech can realize measurable benefits across engineering, quality, regulatory, and product development functions.
Accelerate ALM Modernization
Leverage TCS MedTech Solution Template and proven implementation methodologies to transition from legacy environments to a modern ALM foundation.
Replace Fragmented Tools
Consolidate disconnected systems, spreadsheets, and manual processes into a connected lifecycle management environment.
Establish End-to-End Traceability and Adaptability
Create a governed digital thread connecting requirements, risks, tests, defects, quality records, workflows, and release evidence while adapting to evolving business and regulatory requirements.
Improve Regulatory Compliance
Strengthen governance, visibility, and auditability across the product lifecycle through connected development and quality processes.
Reduce Manual Compliance Effort
Replace manually maintained trace matrices and audit preparation activities with automatically connected product information and evidence.
Drive Adoption Securely at Scale
Support enterprise-wide transformation through implementation expertise, governance frameworks, organizational change management, and best practices.
Enable Faster, Safer Innovation
Deliver smarter, safer, and increasingly software-driven medical products while maintaining confidence in quality and compliance.
Connecting Requirements to Patient Impact
The ultimate goal of Trace360 MedTech extends beyond compliance. It helps organizations create a direct connection between product decisions and patient outcomes.
When requirements, risks, tests, validation activities, quality processes, and release decisions are connected through a single governed environment, teams gain greater visibility into product performance and greater confidence in development outcomes.
Rather than proving compliance after development is complete, organizations can embed quality, traceability, and regulatory readiness into the development process from the very beginning.
Every requirement can be connected. Every risk can be managed. Every test can be traced. Every change can be assessed. Every release can be supported with evidence. Every decision can contribute to better patient outcomes.
A New Standard for MedTech Product Traceability
As MedTech products become increasingly complex and software-defined, complete product traceability is no longer optional. It is a critical foundation for accelerating innovation, ensuring compliance, improving quality, and delivering better patient outcomes.
Trace360 MedTech combines PTC Codebeamer, the TCS MedTech Solution Template, Pravaas migration accelerators, advisory services, ecosystem collaboration, implementation expertise, and organizational change management into a single transformation framework designed for regulated product development.
The result is a connected digital thread that helps MedTech manufacturers modernize faster, improve visibility, strengthen compliance, scale globally, and achieve complete product traceability from requirements to patient impact.
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