A Quality Management System right-sized to your needs
Digitise your document control
Phase gate and document your entire design process
Fast and secure information management
Integrated LMS for training, assessments, and streamlined onboarding
Detect, correct and prevent quality failures
Integrate FDA and ISO 13485 compliant e-signatures into your eQMS
Monitor and manage supply chain quality
Ensure oversight and control with graphical business management
Change control when it matters most
Support for GxP and FDA software validation requirements
Manage documentation and ensure audit readiness
All our helpful resources in one place
Insightful content from our thought leaders
Best-practice guides for your product development
Free templates to help you control your quality management
Success stories from Cognidox customers
Helpful articles about key topics for your product development
Discover how to build a training management system that scales with your needs
Keep med dev projects on track and meet the regulation with complete control over the way documents are handled
A configurable template for NCR reporting that can become part of your Quality Management System
Cognidox helped Coalesce deliver a level of quality control that impressed auditors.
Download our checklist to determine your regulatory responsibilities and help you meet the real demands of 21 CFR Part 11
A dynamic Excel template developed to help you establish an effective supplier assessment process
An in-depth exploration of the medical device development process to help you plan and manage your development cycle
An overview of GxP regulation in the life science industry, helping you understand what is needed to implement, validate and evidence compliance.
Discover the key questions you should ask vendors when choosing an eQMS for your medical device development
DisplayLink needed to implement a solution that would instil program governance, scale with them, and complement their growth
A guide to designing and developing a medical device in a fast-moving and disrupted marketplace.
Find the most powerful, repeatable and cost-effective way to ideate, develop, launch, and manage new high-tech products.
This guide will arm you with the knowledge to not only assemble a design history file, but make that process part of 'the way you do things'.
Discover how you can build and maintain a digital QMS in the most flexible and cost-effective way possible
Demonstrate to regulators and notified bodies how you will structure and maintain the file throughout your product’s lifecycle.
A smart document management system can provide rigour, accuracy and control for your complex product development project.
Here are ten key questions you should ask every vendor to secure the levels of governance you need and the flexibility you want from an eQMS solution.
Discover how document control can improve your flow, accelerate your process and maximise your competitive edge.
The introduction of Cognidox helped UltraSoC establish the structure they needed to grow.
What is GxP and what do you need to do to ensure compliance?
A six-step methodology to help you deliver clear evidence of a risk-based approach to quality.
Discover how to build a training management system that scales with your needs.
A configurable template for CAPA reporting that can become part of your Quality Management System.
Access your free quality management maturity grid to begin measuring your organisation’s approach to quality.
Cognidox's graphical BMS helped Ranplan Wireless achieve fast ISO 9001 certification.
Our free NCR process workflow helps build a simple and effective procedure that everyone in your business can understand and follow.
Definitions of non-conformity you can use in your Quality Management System.
Download the guide to increasing oversight, improving process, and enhancing quality in high tech product delivery.
The difference between document management and document control - and why it matters to the success of your medical device development project.
How a document management system improves your product development.
This guide will explain why and how you should document your business processes in graphical form, making them the beating heart of your operation.
Whether you're running trials as a CRO, scaling production as a CMO, or delivering end-to-end ...
The med tech sector is booming, but many companies are silently leaking time, money and talent ...
It’s the job of your corrective action process to identify and eliminate the systemic issues that ...
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