Glossary Term
Product Lifecycle Management
Definition
Product Lifecycle Management (PLM) refers to the process of managing the entire lifecycle of a product from its initial concept, through design and manufacturing, to service and disposal. PLM integrates people, processes, business systems, and information to facilitate the efficient management of the product's lifecycle. This includes managing product data, improving collaboration across teams, ensuring compliance with regulations, and tracking product performance. In the medical device industry, PLM helps ensure that products are developed, manufactured, and maintained in compliance with industry standards, such as FDA regulations, while optimizing product performance and minimizing costs throughout the product's lifecycle.
Relevance to the MedTech Industry
The aim of PLM is to streamline product development and ensure that a product is efficiently managed throughout its entire lifecycle. By integrating all aspects of the product's journey—design, manufacturing, regulatory compliance, and post-market activities—PLM ensures that a product meets market demands, regulatory requirements, and performance standards while minimizing waste, reducing costs, and improving time-to-market.
Additional Information & Related Terms
Related Terms
Design History File (DHF): A comprehensive collection of documentation that demonstrates the design process and regulatory compliance for medical devices, often managed within PLM systems.
Risk Management: The process of identifying, assessing, and mitigating risks in the product lifecycle. In PLM, risk management documentation ensures that safety and regulatory standards are met.
Product Data Management (PDM): The management of product design data and documentation, typically a subset of PLM, that focuses on the technical data used to create and manufacture a product.
Change Control: The formal process used to manage changes in the product design, manufacturing processes, or materials, which is a critical part of PLM for ensuring consistency and compliance.
Regulatory Compliance (FDA, ISO 13485): Ensuring that products meet the standards and regulations required for safety, effectiveness, and quality. PLM systems help maintain this compliance throughout the product lifecycle.