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PLM For
Medical Device
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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
PLM SOLUTIONS
Next Gen PLM for MedDev Manufacturing
“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.”
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.