The Cognidox Review
Simon Roberts
Cognidox Sales Director l Affordable eQMS for medical device & high tech development l Prices starting from ￡500 per month | ISO 13485, GxP & FDA compliant | Helping quality consultants build a recurring revenue model
Hi there,
Welcome back to the Cognidox Review, where we aim to provide you with a selection of helpful content from our thought leaders.
Enjoy the read!
Digital vs. Electronic Signatures: Ensuring FDA, MHRA, and EU Annex 11 Compliance
Would your business benefit from using electronic signatures within your digital quality management system (eQMS)? Are you hoping they will streamline your sign off processes and strengthen compliance capabilities? If so, what?type?of e-signature do you need?
5 Reasons Why You Need Document Version Control Software
We’ve all been there. We’ve lovingly put the final touches to that important document and saved it to the shared drive. We’ve even labelled the document ‘final version’, so there could be no confusion about its status in the future. Then someone wants to change it.
Demystifying Medical Device Audits: Requirements, Process, and Impact
Medical device audits can be a source of stress for developers and manufacturers. But what exactly are the auditing requirements in the EU and US markets, who will conduct them, when and how?
A Guide to Compiling a DHF for Medical Device Development
The FDA’s new QMSR is dropping the reference to the DHF (Design History File) when it takes effect in 2026. But that doesn’t mean the requirement is being dropped. Here’s what you need to know about the DHF and its ongoing importance in FDA compliance.
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Updates from the world of Cognidox
IVDeology | US IVD Classification of devices: How different can it be?
Addressing the need for high-quality healthcare globally with ISO 7101