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

Design and develop 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 & Development module
do it for you

Our Design & 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

From user needs to design verification and validation

Connect items together seamlessly with version control as well as all necessary review and approval steps in place.

Baked-in risk assessment

Risk assessment exercises can be performed and linked to elements painlessly in every single step of the process.

Automated traceability matrix

Say goodbye to having to deal with updating traceability manually. Once elements are connected through integrations, the traceability matrix is generated and kept up-to-date automatically, and effortlessly.

Advanced reporting and exporting capabilities

Export and send in a few clicks

Our module makes it easy to export all the relevant data quickly into a universally accepted and compressed .ZIP package in order to send it off to regulatory bodies for approval.

 

Our Scilife Design & Development module will be released at the end of 2021!

Excited to help us build the perfect solution?
Let us know and receive a partner discount in return once our new Design & development module is live.