We visited the Med-Tech Innovation Expo to hear about the future of the medical device industry. Here's what we learnt.
Working to GxP isn't easy. But it can be simplified with an electronic software system - if you know what you need to look for.
The FDA announced its intention to harmonise with ISO 13485 last year. That means 3 big changes to how medical device companies comply with CFR Part 820. We take a look at what the future holds.
What does GxP actually mean day-to-day? Learn where your business is strong and where to improve with our compliance checklist.
Laura Cox, Lead Responsible Person at CST Pharma, shares how she embedded Good Distribution Practice into her organisation using electronic quality management software.
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.
Qualsys's Chris Owen reviews the GAMP CoP event.
Economically motivated adulteration is an increasingly prevalent risk to your food supply chain. Learn which steps to take to protect yourself here.
The flexibility of Qualsys's software solution allows customers to apply their own ideas and initiatives. We asked Sirus Quality, Training & Health/Safety Manager Pauline Sourdille how she uses the system day-to-day.
A REACH-compliant chemical supply chain requires information transmission in both directions. Learn what you should be sharing here.
Chemical companies working with hazardous substances must complete an SDS for REACH compliance. Business Development Manager Tom Hodgson explains what to do.
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.
Sodexo's EQMS Manager Rob Gibson explains why his pharmaceutical clients are 'raving' about Qualsys's software solution.
70% of 510(k) FDA submissions are unsuccessful. Qualsys's Senior Business Development Manager Alex Swan shares some tips to help ensure yours isn't one of them.
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?
Medical laboratories have until September 2018 to transition from CPA accreditation to ISO 15189. We created a gap analysis to help you pinpoint what to change, and where.
Here are three mistakes to avoid when planning your Trial Master File.