For Medical Device Manufacturers, enabling validation of enterprise PLM implementations can be complex, expensive and time consuming. That’s why TECHNIA have developed a Life Sciences Cloud PLM package that provides all the benefits of a turnkey ready solution, enabling our clients to focus on their critical business needs.

Key Benefits

Design Control and Development – Requirements

Enable product safety and automation of regulatory needs with a virtual environment for gathering and creating customer requirements that are fully visible and traceable.

Design Control and Development - Design History File (DHF)

Enable the coordination of project activities and New Product Introduction (NPI) tasks to facilitate the completion of design control deliverables, while automatically populating the resulting DHF.

Design Control and Development - Device Master Record (DMR)

Efficiently manage the process of DMR records through automation, while eliminating errors that can occur from multiple information silos and redundant systems, ultimately saving time and improving data accuracy.

Quality Management Systems (QMS)

Relate product information to Complaints, Corrective Actions Preventive Actions (CAPA), Non-Conformance Reports (NCRs) with an effective, global consolidated approach with full traceability by overseeing your quality management on the same platform.

Regulatory Management (RM)

Gain full visibility to regulatory inquiries and answers, allowing you to manage the completeness of your dossier and reduce the risk of delaying Time to Market authorization.

Enterprise Change and Configuration Management (ECM)

Enable compliance and optimize document management, with a flexible, enterprise change control process and structured library management.

MCAD / ECAD integration

Benefit from integrated MCAD tools such as SOLIDWORKS, CATIA, and others, in addition to ECAD tools such as Altium.

Enterprise Integrations

Our exclusive TECHNIA Integration Framework (TIF) means integrating existing ERP and point solutions is easy! Avoid issues associated with siloed information by enabling bi-directional data updates.

Pre-Validated Cloud PLM Solution for Life Sciences

Built around Dassault Systèmes’ ‘License to Cure’ Portfolio, the TECHNIA Pre-Validated Cloud PLM Solution enables Medical Device companies to swiftly adopt a model-based, data-driven approach to product development.

Address your compliance requirements and enjoy the latest 3D design solutions (such as SOLIDWORKS, CATIA and Altium) all without leaving the platform. We’ve even included sets of pre-packaged validation .CSV templates to ensure that you can get straight to work making medical device creation simple and sustainable.

During the last twenty years, TECHNIA’s Global Life Sciences PLM team have established long term relationships with world-leading Life Sciences companies, supporting them in their digitalization journeys. Now we’re able to distil that shared knowledge to create the TECHNIA Pre-Validated Cloud PLM Solution specifically for Medical Device companies, available on TECHNIA.Cloud.

Our experts have developed this package to cover your every requirement, including Enterprise Change Control, Design Control Process, Device Master Records, Discrete Quality Processes, Regulatory Compliance, Enterprise and Point Solution Integration, Computer Software Validation (CSV) and MES (DHR) systems.

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