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.
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.
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.
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 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.
Qualsys have provided these resources to help you stay on top of the ISO 13485:2016 revision and ensure you are prepared for your ISO 13485 certification.