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The FDA’s Quality System Regulation (QSR) for medical device manufacturers is commonly known as FDA 21 CFR Par...
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...
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...
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...
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 ...
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...
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) ...
The rise of RISC-V seems inexorable. It’s being touted as an answer to the drastic slowing of Moore’s law. It’...
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...
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...
A document management system (DMS) is a method of managing, storing and retrieving all the documentation a bus...
In medical device development, document controls are the building blocks of an ISO and FDA compliant Quality M...
Are you looking for ways to build and maintain the most efficient, ISO 13485 compliant QMS as your company con...
DropBox is a file sharing platform familiar to millions throughout the world. Once a personal file storage and...
Inflexible SOPs, complicated interfaces, training and maintenance requirements. Traditional document control s...
ISO 9001 requires you to control the document lifecycle to improve the efficiency and effectiveness of your bu...
Chaotic document management is wasting the time and energy of businesses around the world every year. But in s...
A Quality Management System is a requirement for medical device developers across the globe. But should you bu...
How should you structure your documentation to meet the requirements of ISO 13485?
What are the 7 stages of the document lifecycle? Why is managing and controlling the lifecycle a critical part...
In this blog, Shaun Knights, Head of Quality at period care company Callaly, tells us why his start-up needed ...
Document controls are a fundamental requirement of every medical device regulatory regime. They are the ‘build...
Building a quality management system is never a quick and simple process. But in medical device development, w...
Following Britain’s exit from the EU, all non-UK medical device and IVD manufacturers who want to place their ...
IVD device regulation is about upping the bar—it’s about making products to a higher standard and ensuring the...
ISO 9001:2015 and its related quality standards are all based on the ‘Seven Quality Management Principles’ def...
The Covid pandemic has brought new attention, investment and competition to the IVD sector. But with new oppor...
The EU In Vitro Diagnostics Regulation (IVDR), written in 2017, was developed to replace the existing EU In Vi...
Good Manufacturing Practices (GMP) are intended to ensure that pharmaceutical products, medical devices and ot...
I worked in one of the large Cambridge-based technology consultancies for many years and was privileged to hav...
I believe that a quality strategy is a vital element to the success of a business. Quality of product and oper...
Mention ISO 9001 to most people, or tell them that you implement quality systems, and they'll start glazing ov...
Colocation was one of the central tenets of the Agile manifesto, but times have changed. With all the new digi...
How does your organisation authorise, authenticate, document and police the use of electronic signatures withi...
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