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Change control in life science development is critical to ensuring the safety of patients. Having a formal pro...
Change control in life science development is critical to ensuring the safety of patients. Having a formal pro...
Chip designs are becoming more complex and expensive to develop, verify and validate. Opportunities for fables...
Clinical research demands strict GCP (Good Clinical Practice) compliance. But many institutions stuck with out...
At last! It’s happened! The FDA has announced the date for the publication of its new Quality Management Syste...
Transferring design to production is a process that can be fraught with risk for medical device developers. Ho...
There are many reasons why organisations need to document their SOPs. From ensuring uniformity in end products...
There’s plenty of document management and file-sharing software available on the market, but not all of it is ...
Of all the quality management ‘gurus’, the late Philip Crosby is one of the most readable. In his book ‘Qualit...
The regulations and literature surrounding medical device development are packed with acronyms and technical t...
Will a phase gate process hold back or enhance your new product development? What are the pros and cons of sta...
A Quality Management System (QMS) is a requirement for medical device developers across the globe. But should ...
How can you help your business evolve its mindset to achieve the most instinctive, frictionless and effective ...
Dropbox is an easy to use cloud storage and sync application that is increasingly used in work settings for fi...
The FDA’s Quality System Regulation (QSR) for medical device manufacturers is commonly known as FDA 21 CFR Par...
The medical device development process is typically broken down into five distinct phases. Each one requires i...
It’s the job of your corrective action process to identify and eliminate the systemic issues that will prevent...
SMEs creating a digital Quality Management System (QMS) will often reach for the most familiar tools to build ...
Monitoring and measuring quality of products and services is a key part of any QMS. But how can you be sure th...
Google Drive is a cloud-based program that allows you to create, edit, store, and share documents. Many busine...
How do you log and deal with non-conformities so that faulty products don't end up in the hands of customers? ...
What is the medical device technical file? What should it contain and how should it be structured? And is it e...
Document control is a key part of any Quality Management System (QMS) and, therefore, a requirement of ISO 900...
How do you transform regular supplier reviews from a box-ticking exercise into a genuinely useful commercial a...
What’s wrong with SharePoint, anyway? Why shouldn’t it be used as a document management system (DMS) for a gro...
Does the fertility tracking app you are developing count as a medical device? What about the imaging software ...
ISO 9001 is the internationally recognised standard for quality management used in many sectors from construct...
The PIP scandal, in which thousands of women were injured by faulty breast implants over a period of twenty ye...
How is the quality of your document review process affecting the speed and efficiency of the way you do busine...
We’ve all been there. We’ve lovingly put the final touches to that important document and saved it to the shar...
Question for you: what exactly is a medical device? Is the product you are developing a Medical Device, an In ...
So, you’ve had your brilliant idea. You know what kind of medical device you want to build. You have a vision ...
Medical device audits can be a source of stress for developers and manufacturers. But what exactly are the aud...
Having a repeatable procedure for Corrective and Preventive Action (CAPA) is a key FDA requirement for medical...
There are different ways companies can build required quality management systems, from using traditional paper...
What are the planning requirements for a medical device design and development process? And what tools can hel...
WTH is FDA 21 CFR Part 11? That’s a question many medical device developers wanting to access the US market mu...
A focus on a quality management system shouldn’t just mean a ‘box ticking’ exercise for an organisation. And i...
When it comes to medical device development, the absence of comprehensive design and development documentation...
How can medical device developers gain FDA approval for their devices and permission to sell their product int...
Qualio is an eQMS platform launched in 2012 by Irish entrepreneur Robert Fenton. From small beginnings, his co...
Good documentation practices (also known as GdocP or GDP) are guidelines for document management and control d...
Many medical device consultancy practices work on a fee-based model, helping clients with regulatory and quali...
A QMS should ultimately help guard against customer harm or dissatisfaction, by guarding against the risk of f...
Developers who want to release a medical device in the US need to seek permission from the FDA. Depending on t...
The semiconductor shortage continues to ravage many sectors. With its reliance on electronics for driverless t...
Greenlight Guru has been marketed since 2013 as the first digital eQMS (electronic Quality Management System) ...
Migrating to a new eQMS is a big step for any medical device company, with many pitfalls for the unwary. What ...
The rise of RISC-V seems inexorable. It’s being touted as an answer to the drastic slowing of Moore’s law. It’...
Having a document control system in place is a requirement of quality standards and regulations around the wor...
Cambridge, UK, 3 May 2022: Cognidox, a leading provider of document management solutions for the high-tech, me...
DHF, DMR, DHR… to the uninitiated they might sound like out-of-town furniture stores or airport codes for exot...
For some companies simply managing their documentation is enough to support their business goals. But others n...
QC is about detecting defects in your finished product, while QA is about preventing the defects from occurrin...
The Device Master Record (DMR) is one of the ‘holy trinity’ of files that developers need to collate and maint...
30 years ago the FDA introduced robust new requirements for medical device design control following a string o...
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