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Hand drawn illustration of a box  and a ruler to represent Design & Development Module of Scilife's Platform

Design and Development Software 
According to ISO 13485

Manage the whole design & development process according to strict compliance regulations and bring your medical device to market faster.
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Linking documents together through folders isn’t going to cut it

Have you tried this with MS Word and Excel files? Or even with standard document management solutions? We know, it doesn't work.

Let our Design and Development module
do it for you

Our Design and Development module is purpose-built to impeccably follow the process as stipulated by the ISO 13845 regulation, no risky shortcuts! We make it easy to link elements, maintain version control, use compliant electronic signatures and streamline risk assessment.
Screenshot of Design & Develop Module Overview on Scilife Platform

A single effective workflow covers the
entire design and development process

Streamline whole process

Do you want to go from user needs to design verification and validation faster? Streamline your design and development process from inception to launch so that you can accelerate to market. If you are a medical device company and need fast, efficient regulatory lifecycle management, the Scilife Design and Development solution is for you.

Ensure full traceability

Eliminate confusion over tracking of documents in the design and development workflow. With our traceability matrix, you can quickly determine how a particular design input relates to user needs, how a design change can impact your design validation process, and how any change can impact your testing and verification processes.

Single-click submissions

No more hours of manually compiling data and documents. Control all documents in the cycle for foolproof regulatory submissions. With a single click, thousands of documents can be exported and packaged in one file that can be shared with regulatory bodies. 

Our Scilife Design and Development will be released in 2023!