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Medical device development

How best to navigate the complexities and opportunities of med tech?

With a document management system that can adapt to the unique way you work, while meeting the demands of regulated industry

Success in the medical device sector depends on the rigour of your processes, good operational governance, and rock solid design controls, But SMEs don't want to be restricted by needless bureaucracy. An adaptable, cloud based Document Management System can help define and drive an efficient but robust approach to med tech development, so that quality simply becomes 'the way you do things'.

How Cognidox Helps

Record, store and index every document from ideation through to release and upgrade, and make regulatory submission as easy as the 'touch of a button'.

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Some med tech eQMS options are clunky and prescriptive in the way they operate. Cognidox is adaptable, scalable, and designed to flex with your needs

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Regulatory Submissions

 

Compile and publish your Design History File and other technical files at the touch of a button. Seamlessly manage regulatory submissions and audits required by ISO 13485, EU Notified Bodies and the FDA. 

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Rock solid change-control

 

Ensure your change control management is water-tight, with phase-gating and document approval processes built into the way you work and iterate your product.

 

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Software Validation

 

Cognidox helps you meet all the robust demands of software validation regulations required by ISO 13485 and 21 CFR Part 11

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So, you want to be a successful medical device developer?

Then download this guide to get an in-depth exploration of a best practice approach to the medical device development process.

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