.svg "\"\"")
As the 2020 deadline for compliance with the EU’s new Medical Device Regulation (MDR) fast approaches, the EC’...
As the 2020 deadline for compliance with the EU’s new Medical Device Regulation (MDR) fast approaches, the EC’...
The Good Automated Manufacturing Practice (GAMP 5 ®) guidelines define a set of core principles for GxP, as pr...
Many high tech businesses who are implementing a Quality Management System (QMS) to gain ISO 9001:2015, are in...
In 1969 quality management was truly the final frontier in the space race. As NASA engineers developed unique ...
A change control process is a vital part of any product development and management function. But if it’s not e...
Advanced Driver Assistance Systems (ADAS) and even driverless cars, once the stuff of science fiction, are rap...
A responsive new product development (NPD) process has always been a key part of a high tech business strategy...
Can you ever make a stage-gate process Agile? Can modern tools and a hybrid approach to Waterfall and Agile br...
Not all business management software solutions are created equal. They come in different shapes and sizes, wit...
Time and costs can soon rack up in a med tech device design and development cycle. But those who have installe...
Issuing a tech product release or a software update can be a challenging process. Handled badly it can result ...
I am a former FDA staff member and now back in the private sector. If you are in Regulatory Affairs, you are i...
From 2022 the In Vitro Diagnostics Regulation (IVDR) will require Notified Body intervention and review for 80...
Google Drive and Dropbox are two of the most popular cloud-based, file-sharing platforms on the market today. ...
From 2020 and 2022, EU Medical Device Regulations will change. This brings certain products into regulatory sc...
Do your systems give you the kind of control over your documentation which really match the organisational, co...
A med tech device that has a poor user experience can be dangerous for consumers and commercially calamitous f...
Google Team Drive is a service which has been available by default to Business, Enterprise and Education G-Sui...
For many companies, compliance is, at best, regarded as a necessary evil, and at worst a never-ending ordeal. ...
There is always commercial pressure on product developers to find better and more efficient ways to collaborat...
Both Box and Dropbox Business are cloud-based file sharing solutions intended to give their customers the free...
Founders of companies are often, by necessity, their own Product Managers. They’re often the ones who have mos...
OK, we admit it, there are definitely more than 7 deadly sins of the product development process. In fact, the...
Box is a popular cloud-based, file sharing solution, designed for use by enterprises to store business documen...
With a supply chain ripe for digital disruption, high tech manufacturing companies must evolve new ways of man...
Document control is a crucial part of any project management process. In this blog post we ask how the right D...
We all make mistakes, but when a product development process fails it can have far-reaching financial and comp...
Business Process Maps are a key part of any Company Management System. They are the flow diagrams that help yo...
There are many competing demands on the attention and resources of a growing business, but investing in the ri...
What is the best document management solution for you and your business, One Drive for Business or SharePoint?...
In part one of this series we argued that one key ingredient for a successful scale-up company is optimisation...
Reports from the U.S. tell us the FDA is continuing to prioritise Proactive Quality Management in the medical ...
Our opening post on this theme introduced the problems that companies face as they transition from start-up to...
One of the main challenges of implementing a Quality Management System (QMS) is ensuring it is actually used f...
It seems everyone is talking about Scale-up companies these days. The term has been around since 2013 (see for...
Business Process Mapping could be the first step you take towards creating a more efficient, profitable and qu...
As we approach the end of 2018 with all its political and economic earthquakes, how can your high tech company...
Adopting a Business Management System (BMS) is a well-established way to manage and control all the processes ...
A failing product development process can cost your sanity, your company’s reputation, and a lot of money. In ...
If you’ve been focused on improving your company’s Quality Management System it’s likely you will have encount...
Delays are the biggest challenge for any product development cycle, they annoy clients, they sap the creative ...
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 ...
Are you wasting money in a messy product development process? Are you constantly losing sight of your prioriti...
For companies in the high tech sector, where time is precious and resources costly, a single mistake can be ve...
Digital signatures are proving valuable tools for businesses developing products for release in highly regulat...
New version enables faster, simpler intranet creation and easier FDA record compliance Cambridge, UK, 20 Septe...
The early stages of any start-up are critical to the overall success of the business. In product development, ...
In the white heat of the product development cycle there is always the potential for chaos. And high tech busi...
Good collaboration is at the heart of business success. And with the vast array of digital tools available to ...
One of the hallmarks of innovative organisations is that they are very good at developing ideas into successfu...
At a time of innovation and increasing traction in IoT, the recent acquisition of S3 Semiconductors by Adesto ...
Cambridge, UK, 1 August 2018 - Cognidox, the leading provider of document management solutions for the high-te...
Most high tech companies have multiple products. And most products combine different project deliverables - ha...
Most people think of document security only in relation to highly sensitive documents. However, the security o...
%20(1).webp?width=133&height=76&name=ISO%20IEC%2027001%20(1)%20(1).webp)