Entries by Johnnie Dahlberg

Welcome Melanie and Daniel!

We are pleased to introduce two new team members who will be strengthening our efforts in the Sales Department and Quality & Regulatory Services. Melanie brings a background in Mechanical Engineering with a focus on medical devices. As a Junior Consultant, she will be a valuable addition to our team of quality and regulatory consultants. […]

In most 510(k)s the FDA does not require clinical data, and class 1 devices are generally exempt from premarket submission requirements. Therefore, some companies conclude that they can save considerable time and money by not performing expensive studies…But is that really true? The U.S. Food and Drug Administration (FDA) has established three regulatory classes based […]

Labquality acquires QAdvis AB

Labquality strengthens its regulatory affairs service capabilities and expands to Sweden. Labquality, supported by Mérieux Equity Partners, acquires QAdvis AB. Read the full story here!

Free Seminar – Incident Reporting/PMS – 19 June – Kista

Let’s talk about incident reporting, one of the important Post Market Surveillance activities for companies that place medical devices on the market. Information After years of development and testing, bringing your medical device to market is an exciting achievement.  However, your work isn’t finished yet. Once your product is in the hands of the public, […]