Does the fertility tracking app you are developing count as a medical device? What about the imaging software ...
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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 qua...
A QMS should ultimately help guard against customer harm or dissatisfaction, by guarding against the risk of...
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...
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...
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 mai...
30 years ago the FDA introduced robust new requirements for medical device design control following a string o...
A Quality Management System (QMS) is a requirement for medical device developers across the globe. But should ...
A document management system (DMS) is a method of managing, storing and retrieving all the documentation a bus...
An Electronic Document Management System (EDMS) is a software that centrally stores and organises documentatio...
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...
With complexity and costs rising, fabless semiconductor companies need to do all they can to keep their flow a...
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...
The case for ditching paper-based QMS (Quality Management Systems) can seem like a no-brainer. But faced with ...
Google Drive is a cloud-based program that allows you to create, edit, store, and share documents. Many busine...
What are the 7 stages of the document lifecycle? Why is managing and controlling the lifecycle a critical par...
In this blog, Shaun Knights, Head of Quality at period care company Callaly, tells us why his start-up needed ...
It’s the job of your corrective action process to identify and eliminate the systemic issues that will prevent...
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 ...
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