PLM For
Medical Device

Unlock the full potential of your product lifecycle with Domain Systems’ PLM Services

See A Propel PLM Medical Device Demo In Action

Don’t miss out! Join us for an exclusive Propel PLM Demo and Q&A video. Discover the power of Propel’s cutting-edge features and learn how it can revolutionize your product lifecycle management. Watch now and propel your success!

DISCRETE MANUFACTURING: MEDDEV

Navigate the complex landscape of healthcare regulations while ensuring your medical device products are top-tier and ready for market.

Efficiently meeting FDA requirements is crucial in the medical device industry. Product Enterprise PLM ensures FDA regulatory compliance by providing comprehensive and accurate content for product design and then to support management decisions across organizations and functional groups.

PLM Addresses Your MedDev Challenges

null

Interdisciplinary Coordination

Medical device development often involves a wide range of disciplines, from engineering to regulatory affairs. Coordinating these different teams and ensuring everyone is working from the same information can be a significant challenge. Without a robust PLM system, miscommunication and errors can occur, leading to costly delays and rework.

null

Regulatory Documentation

The medical device industry is heavily regulated, and companies must maintain detailed documentation to demonstrate compliance. Managing this documentation can be a significant burden, particularly when changes are made to the product design or manufacturing process. A PLM system can streamline this process, but without it, companies risk non-compliance and potential penalties.

null

Product Lifecycle Traceability

From initial concept to post-market surveillance, medical device companies must track their products through every stage of the lifecycle. This traceability is crucial for regulatory compliance and for managing product changes. Without a PLM system, maintaining this level of traceability can be complex and time-consuming.

null

Risk Management

Risk management is a critical aspect of medical device development. Companies must identify potential risks, assess their impact, and implement mitigation strategies. This process can be complex and requires a systematic approach. Without a PLM system, risk management can become unmanageable, potentially leading to product failures or regulatory non-compliance.

null

Integration with Other Systems

Medical device companies often use a variety of software systems, from CAD tools to ERP systems. Integrating these systems can be a significant challenge, but it’s crucial for maintaining data consistency and efficiency. Without a PLM system that can integrate with these other tools, companies may struggle with data silos and inefficient workflows.

null

Managing Product Variants

Many medical devices come in multiple variants, each with its own specifications and regulatory requirements. Managing these variants can be a significant challenge, particularly when changes are made to the product design. Without a PLM system, companies risk errors and inconsistencies, which can lead to quality issues and regulatory non-compliance.

PLM SOLUTIONS

Next Gen PLM for MedDev Manufacturing

Client Success

“It was very nice working with Domain team, every team member was professional, courteous and delivered timely with good quality. Engineer(s) were experienced and knowledgeable, they responded very timely and took proactive steps. Project management process was also very much satisfactory and met expectations of the team member for all respects.”

null

Sanjeev Tripathi

Senior Business Analyst
Conformis.

FAQs

How can a PLM solution benefit medical device companies in managing complex product development processes?

A PLM solution offers significant benefits for medical device companies in managing complex product development processes. It provides a centralized platform for managing product data, documentation, and collaboration. PLM solutions enable efficient version control, change management, and facilitate cross-functional collaboration, resulting in streamlined processes, reduced time to market, and improved product quality.

Can a PLM solution support compliance with regulatory standards and quality requirements in the medical device industry?

Yes, a PLM solution can support compliance with regulatory standards and quality requirements in the medical device industry. It provides features for capturing and managing regulatory requirements, tracking changes and approvals, and ensuring traceability. PLM solutions help medical device companies adhere to regulations such as FDA guidelines, ISO standards, and other industry-specific requirements.

How does a PLM solution assist in managing the complexities of product design and engineering in the medical device industry?

A PLM solution assists in managing the complexities of product design and engineering in the medical device industry by providing advanced tools for design data management, version control, and collaboration among design teams. It enables efficient management of design revisions, facilitates design validation, and ensures compliance with design controls and risk management processes.

Can a PLM solution facilitate effective collaboration between cross-functional teams and suppliers in the medical device industry?

Yes, a PLM solution can facilitate effective collaboration between cross-functional teams and suppliers in the medical device industry. It offers features for secure document sharing, real-time communication tools, and bidirectional data exchange capabilities. PLM solutions enable seamless collaboration, fostering efficient communication, knowledge sharing, and coordination among stakeholders across different functions and organizations.

How can a PLM solution contribute to post-market surveillance, including complaint management and product lifecycle monitoring?

A PLM solution can contribute to post-market surveillance in the medical device industry by providing features for complaint management, adverse event tracking, and product lifecycle monitoring. It enables efficient management of complaints, facilitates investigation and resolution processes, and supports vigilance reporting to regulatory authorities. PLM solutions help ensure product safety, quality, and compliance throughout the entire product lifecycle.

HAVE A QUESTION?

We realize that often there are questions that remain unanswered feel free to reach out and ask us more about PLM Solutions for MedDev products.

Get Help »

Clients we serve in the Medical Device vertical market

Blogs

Agile PLM installations: Hosting or On-Premise and things to consider

AGA Case Study

AGA Medical: 83% Faster Time to Close Product Change Orders

Video

The 10 Most Common PLM Mistakes