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EU Annex 11 provides guidelines for the use of computerised systems in ensuring Good Manufacturing Practices (...
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EU Annex 11 provides guidelines for the use of computerised systems in ensuring Good Manufacturing Practices (...
ISO 14971:2019 defines the international requirements of risk management systems for medical devices. How does...
Dubbed the 'combination of money and molecules', Biotech is a famously hard sector in which to find and fund s...
Post-Brexit, there is still confusion about the future use of the UKCA (UK Conformity Assessed) markings and w...
Transferring data to a new electronic Quality Management System (eQMS) can seem like a daunting prospect. Here...
On the 16th of May, Cognidox welcomed nearly 100 attendees from across the high-tech, medical device, and phar...
Managing the integrity and accessibility of a PSMF (Pharmacovigilance System Master File) is a key challenge f...
What does it mean to 'control documents'? And who needs a formal document control system to manage and optimis...
Managing deviations from standard operational procedures is critical to product quality and regulatory complia...
The Cognidox team is delighted to announce we will be hosting CogniCon 24 on 16 May 2024. This is a networking...
ICH Q8 R2 are international guidelines for ensuring Quality by Design in pharmaceutical development. Here’s wh...
Data integrity is central to the safe development and manufacturing of every life-science product on the marke...
The case for ditching paper based QMS (Quality Management Systems) can seem like a no-brainer. But with choice...
In 2008, the ICH Q10 Pharmaceutical Quality System (PQS) guidelines introduced a comprehensive model for an ef...
Cognidox and Qualio are both digital quality management systems (QMS) with a focus on the life science and med...
In medical device development, two critical stages of the design process are often confused: design verificati...
What if you could gain approval to sell your medical devices anywhere in the world, by completing a single, re...
What’s the cost of quality? Can it, like QM guru Philip Crosby argued, really be free? Like most things in bus...
Controlling and documenting IQ, OQ and PQ effectively is a complex and time-consuming process for life science...
Cognidox are delighted to announce the release of our new DocuSign e-signature integration. The new plug in is...
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...
In February 2024, the FDA published its final rule for the new Quality Management System Regulation (QMSR). So...
Transferring design to production is a process that can be fraught with risk for medical device developers. Ho...
Writing clear, compliant Standard Operating Procedures (SOPs) is key to quality management in regulated indust...
There’s plenty of document management and file-sharing software available on the market, but not all of it is ...
Will a phase gate process hold back or enhance your new product development? What are the pros and cons of sta...
Is your approach to quality management ad hoc, analytical, or instinctively agile? In this post, we explore ho...
If you’re a tech start-up or growing SME looking to implement an enterprise-grade file-sharing solution and co...
If you’re developing or manufacturing medical devices in the U.S., complying with FDA 21 CFR Part 820—also kno...
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...
Supplier Quality Management (SQM) is critical for ISO 9001, ISO 13485, and FDA compliance—but many organisatio...
Does the fertility tracking app you are developing count as a medical device? What about the imaging software ...
ISO 9001 and ISO 13485 are both internationally recognised quality standards, but they serve different industr...
We’ve all been there. We’ve lovingly put the final touches to that important document and saved it to the shar...
When developing a healthcare product, it's crucial to determine its classification: Medical Device (MD), In Vi...
So, you’ve had your brilliant idea. You know what kind of medical device you want to build. You have a vision ...
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...
To launch a medical device in the US, developers must gain FDA permission. For most Class II devices, this inv...
The semiconductor shortage continues to ravage many sectors. With its reliance on electronics for driverless t...
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...
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