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When you’re under pressure to gain ISO 13485 or accelerate FDA QMSR compliance, the idea of prompting ChatGPT ...
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When you’re under pressure to gain ISO 13485 or accelerate FDA QMSR compliance, the idea of prompting ChatGPT ...
Are you looking for ways to build and maintain the most efficient, ISO 13485 QMS as your company continues to ...
Bringing a medical device to market is one of the most rewarding and high-stakes journeys a startup can undert...
For medical device startups, implementing a Quality Management System (QMS) isn’t a one-time event - it’s an o...
A Quality Management System is a requirement for medical device developers across the globe. But should you bu...
When you bring a medical device to market, you’re stepping into one of the most competitive and regulated indu...
SMEs creating a digital Quality Management System (QMS) often turn to familiar, digital tools to build a solut...
Training management is a big deal for medical device developers. Get it wrong, and you risk fines, product rec...
There are different ways companies can build required quality management systems, from using traditional paper...
There are many eQMS platforms out there that have been helping medical device developers bring their products ...
Short answer? Yes. But not in the way you'd expect—and that’s been the secret to its success. Here’s the truth...
For some companies simply managing their documentation is enough to support their business goals. But others n...
MasterControl is one of the most widely known electronic Quality Management Systems (eQMS) in the life science...
Transferring data to a new electronic Quality Management System (eQMS) can seem like a daunting prospect. Here...
How do you log and deal with non-conformities so that faulty products don't end up in the hands of customers? ...
Data integrity is central to the safe development and manufacturing of every life-science product on the marke...
Navigating the complexities of ISO 13485:2016 can seem daunting, but understanding its requirements is crucial...
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...
Writing clear, compliant Standard Operating Procedures (SOPs) is key to quality management in regulated indust...
Of all the quality management ‘gurus’, the late Philip Crosby is one of the most readable. In his book ‘Qualit...
Monitoring and measuring quality of products and services is a key part of any QMS. But how can you be sure th...
Supplier Quality Management (SQM) is critical for ISO 9001, ISO 13485, and FDA compliance—but many organisatio...
ISO 9001 and ISO 13485 are both internationally recognised quality standards, but they serve different industr...
A focus on a quality management system shouldn’t just mean a ‘box ticking’ exercise for an organisation. And i...
Qualio is an eQMS platform launched in 2012 by Irish entrepreneur Robert Fenton. From small beginnings, his co...
A QMS should ultimately help guard against customer harm or dissatisfaction, by guarding against the risk of f...
DropBox is a well-known cloud storage and file-sharing platform. Its sleek interface and seamless collaboratio...
Inflexible SOPs, complicated interfaces, training and maintenance requirements. Traditional document control s...
Chaotic document management is wasting the time and energy of businesses around the world every year. But in s...
ISO 9001:2015 and its related quality standards are all based on the ‘Seven Quality Management Principles’ def...
I believe that a quality strategy is a vital element to the success of a business. Quality of product and oper...
Managing the quality of medical products as they are stored and distributed brings with it many challenges. Di...
Around the world different rules apply for the cultivation, manufacture and sale of cannabis and CBD products....
One of the areas included in the ISO 9001 :2015 is 7.1.6 Organizational knowledge. The stated requirement is: ...
Companies working in heavily regulated sectors might have been historically slow to change and optimise their ...
Time and costs can soon rack up in a med tech device design and development cycle. But those who have installe...
Struggling to get your teams to actually use your Quality Management System (QMS)? In this guide, we explore h...
It’s a cliche that good collaboration and teamwork maximises productivity. But in the high tech product develo...
Is ISO certification the only reward you’ll receive for jumping through all those QMS hoops? And is it really ...
4 steps to getting ISO9001 ready Achieving ISO9001 compliance can appear daunting, but while it requires a sig...
There are twelve posts in this series. To read Part XI, please click here. This is the final part in our serie...
When gaining ISO 9001 certification is your goal, it’s tempting to treat it as a box-ticking exercise—doing th...
There are twelve posts in this series. To read Part X, please click here. If you have been reading this blog r...
There are twelve posts in this series. To read Part IX, please click here. In this and the following two posts...
How to apply Risk-based Thinking to Quality Processes - a Summary There are twelve posts in this series. To re...
RISK MANAGEMENT METHODOLOGY FOR QUALITY MANAGEMENT Steps 4-6 in the method There are twelve posts in this seri...
There are twelve posts in this series. To read Part VI, please click here. Steps 1-3 in the method If you have...
There are twelve posts in this series. To read Part V, please click here. Risk based thinking is the new 'prev...
SO 31000 Risk management techniques - continued Attributes of a selection of risk assessment tools There are t...
Most Quality Control and Quality Assurance methods are concerned with business process mapping as a way of und...
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