Corporations often try to unlock value by matching their structures to their strategies. Here's why an integrated qms is essential during a restructure.
Qualsys has helped over 400 businesses to be confident they are audit ready 24/7. Here are 15 lessons we’ve learned to prepare businesses for supplier, regulatory and certification body audits.
Here are three groups of people you'll come across when implementing EQMS and how to manage their expectations throughout the journey.
We asked our customers about the 3 top methodologies quality professionals should be applying. Here's what they said.
Every business strives to achieve a quality culture. Here's how EQMS is an essential tool for a culture of quality at Alliance Medical.
We've launched our new health check report and found our three strongest customer systems for the last month.
Whether it's a near-miss, critical incident or an employee displaying COVID-19 symptoms, your health and safety team need to know in seconds. Here's how.
Stewardship, data and governance initiatives that stick. Ian Brandon from the Good Governance Institute shares his insights from his work with the NHS.
How to fight for resources and recognition, and raise the profile of quality in an industry too focused on profit.
A culture of continuous improvement requires resilience, time & energy. It takes more than a single tool to achieve your quality goals. Here's our catalogue of services improve your quality culture.
Don't know your CTX from your CRISP? Access our acronym dictionary and slice through the quality jargon.
Meet Dan Moorewood, Qualsys' Implementation Analyst.
Here are 8 reasons your medical device company should ditch paper and invest in an electronic quality management system.
View CAD files or a single layer in EQMS Document Manager to improve workflow fluidity, prevent costly mistakes and have confidence in your compliance.
We visited the Med-Tech Innovation Expo to hear about the future of the medical device industry. Here's what we learnt.
Validation costs putting your business off implementing a desperately needed integrated quality management system? Here's how our 5 step validation process genuinely makes it pain-free, efficient and easy to maintain.
Good practice (GxP) guidelines help businesses make products that are safe and fit for use. Read about the various requirements and how they protect quality.
Qualsys customer York Instruments have brought their revolutionary medical device one step closer to market with a flying-colours ISO 13485:2016 audit.
DYSIS Medical's Quality & Regulatory Manager Paul Houston shares his industry experiences and discusses the impact of Qualsys's software on his business.
York Instruments Quality Manager Stewart Wilson discusses how he built a quality management system from scratch to bring a new medical device to market - and why he doesn't prepare for his audits.
We asked three of our customers to share their insights and advice for building a life science electronic quality management system. See their responses here.
Find out how Qualsys's software helps you comply with ISO 13485:2016 Design controls.
A Target Product Profile (TPP) provides a statement of the overall intent of the development program. But with all the other quality and compliance documentation you have to manage in medical devices, you are probably wondering - do I really need a TPP?
How to manage risk for medical devices using ISO 14971 and Qualsys's software.
How Qualsys's software helps with ISO 13485:2016.
We asked our life science readers to share their tips and insights for quality management in one of the world's most challenging sectors. Read their thoughts here.
The new Medical Device Regulation will require many organisations to have a dramatic overhaul of how they plan, manage and record their business processes. Here, Dave Beard shares 3 tips to help you comply with the regulation.
What are the differents between ISO 13485 and ISO 9001:2015
This article explains ISO 13485 requirements for software validation and how Qualsys helps your business meet the ISO 13485 software validation requirements.
Qualsys are delighted to welcome pharmaceutical development company Nanopharm as a new EQMS customer. Read why and how the company will be using EQMS here.
6 tips for optimising your medical device quality management system to meet the requirements of ISO 13485:2016.
Get an overview of ISO 13485 in under 5 minutes. Links also to our new ISO 13485:2016 toolkit.
02-09-20
18-02-20
01-07-20