Plural Technology Private Limited

Life Sciences

In the Life Sciences industry, Product Lifecycle Management (PLM) serves as a pivotal strategic framework that extends far beyond traditional product development. It is an essential system for managing the entire lifecycle of medical devices, pharmaceuticals, and healthcare technologies, from the initial concept through to market deployment and ongoing support.

PLM offers a robust infrastructure designed to address the complex and highly regulated nature of life sciences products. With rigorous regulations imposed by multiple global health authorities, PLM ensures that each stage of development is thoroughly documented, tracked, and validated. This comprehensive approach is vital for upholding the highest standards of patient safety, product quality, and regulatory compliance.

Regulatory Landscape and Compliance

The Life Sciences industry functions within a highly regulated environment, subject to a complex framework of requirements set by global health organizations, such as

  • FDA (Food and Drug Administration): The primary regulatory body in the United States.
  • EUMDR (European Union Medical Device Regulation) by EMA (European Medicines Agency) and the European Commission: Comprehensive regulations governing medical devices in the European Union.

Benefits of PLM

Comprehensive regulatory compliance management
Rigorous quality control tracking
Detailed clinical trial documentation
Accelerated medical device innovation
Complete product history and traceability
Unique device identification (UDI) management
backlog
Global regulatory complance

Challenges Addressed by PLM

Navigating complex global regulatory requirements
product-management
Managing intricate product development cycles
Implementing stringent quality management processes
Ensuring patient safety and product efficacy
Maintaining comprehensive documentation
Tracking and managing unique device identifiers (UDI)

The Role of UDI in Product Lifecycle Management

Unique Device Identification (UDI) has become a crucial component of PLM in the life sciences industry. 

Provides a unique identifier for medical devices
Enables precise tracking throughout the product lifecycle
Supports improved patient safety
Facilitates effective recall management
Enhances supply chain transparency
Supports regulatory compliance across global markets

Case Studies

Innovative Engineering for Industrial & Commercial Markets

Innovative Engineering for Industrial & Commercial Markets

Innovative Engineering for Industrial & Commercial Markets

Our customer is a leading global technology, software, and engineering company providing innovative solutions in industrial and commercial markets. One of their electrical solutions groups…
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Advancing Defense with Cutting-Edge R&D

state-of-the-art systems and technologies

Advancing Defense with Cutting-Edge R&D

Our customer is a research and development laboratory responsible for the design and development of state-of-the-art systems and technologies required for the defense of the…
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Enhancing Change Management Using ARAS Innovator

Enhancing Change Management

Enhancing Change Management Using ARAS Innovator

A global leader in manufacturing and technology sought to optimize its Change Management processes to drive efficiency and improve collaboration. With a strong commitment to…
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Integration of ARAS Innovator with Solidworks EPDM

Integration of ARAS

Integration of ARAS Innovator with Solidworks EPDM

A growing leader in commercial space was using SolidWorks EPDM for CAD design and reviews. They aimed to leveragevarious solutions from ARAS innovator movingaway from…
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PLM in Life Sciences

The integration of advanced PLM systems with UDI tracking and multi-regulatory compliance mechanisms ensures that medical technologies meet the highest standards of safety, efficacy, and innovation.

Get in touch with Plural for your PLM needs

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