Welcome back to 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
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!
Biotech Startup Companies: How to Take on the Pharma Giants and Win
Dubbed the 'combination of money and molecules', Biotech is a famously hard sector in which to find and fund success. But, research shows that small Biotech startups are now winning more drug approvals than their pharma giant counterparts. How has this happened, and how can others replicate their success?
7 Essential Stages of New Product Development: A Comprehensive Guide
A brief internet search will confidently tell you that there are anywhere between 4 and 8 stages of the ‘ideal product development process’. But however your business chooses to break down the different phases that lead from ideation to launch, there is a real need to develop a systematic approach to product development.
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Navigating UKCA Marking for Medical Devices: What You Need to Know
Post-Brexit, there is still confusion about the future use of the UKCA (UK Conformity Assessed) markings and when they must appear on our products and packaging. Here's what medical device developers need to know about transitioning from the EU CE marking to the UKCA.
Understanding FDA 21 CFR Part 11: A Guide for Life Science Developers
What is FDA 21 CFR Part 11? That’s a question many life science developers wanting to access the US market must have asked themselves - in one way or another. It’s easy to be intimidated by the slew of schedules and initials you’ll be confronted with when trying to break this huge and powerful marketplace, so here’s a guide to help you understand what Part 11 really means for you.
Are you just managing or are you in control?
How to end the anarchy with document control & ISO 13485.
Download an Introduction to Document Control for Medical Device Developers here.