PLM for Medical Devices
Guarantee FDA and MDR regulatory compliance and accelerate your development cycles by 30%.
Trusted by
Challenges in the medical devices industry
Aletiq centralizes your technical and regulatory data in a single source of truth. Compliance guaranteed, innovation accelerated.
Why choose Aletiq for Medical Devices?
Benefits of Aletiq PLM software
100%
traceability and compliance with AS and EN
-30%
On Time-to-Market
-90%
of time spent researching data
What sets Aletiq apart
PLM built for Medical Devices
Medical device manufacturers operate in one of the most strictly regulated environments in the world. Between ISO 13485, MDR and FDA, every process must be documented, traceable and auditable at all times.
Aletiq is the PLM software built to meet these demands without adding complexity to your teams' daily work. Regulatory file management (DHF, DMR, DHR), FDA-compliant validation workflows and quality management are natively integrated into the platform, so your teams accelerate time to market with full confidence.
Moria centralizes its DT, DHF and DMR regulatory files
Cyril Prudhomme
,
R&D director
“The extremely rapid implementation of the tool and the loading of all of our historical data by Aletiq allowed a very strong adoption by the teams and a rapid ROI.”
regulatory compliance
On Time-to-Market
time for data management
All you need to know
Aletiq centralizes technical data and manages regulatory documentation (DHF, DMR, DHR), product changes and quality workflows in a single environment built to meet ISO 13485, MDR and FDA requirements.
Aletiq provides full traceability of every component, change and validation across the entire product lifecycle, from design to end of life. Every action is documented and auditable at any time, making inspections and audits straightforward.
By centralizing data and automating validation and engineering change workflows, Aletiq reduces product development cycles by 30%. As a single source of truth, the platform minimizes back-and-forth and errors caused by fragmented data.
Yes. Aletiq is designed to integrate with your existing business tools, including CAD, ERP, MES and quality tools, ensuring data continuity without disruption to your processes.
Aletiq deploys significantly faster than traditional PLM systems, with no heavy integration projects required. Deployment takes an average of two months per site, depending on the volume and complexity of the data to migrate and the connectors to set up with your existing tools.
Unlike traditional PLM systems, Aletiq offers an intuitive interface and fast deployment. Regulatory file management (DHF, DMR, DHR), validation workflows and ISO/FDA/MDR/IVDR compliance are built in from day one, with no lengthy configuration phases required.
