Embedding Quality Management in Medical Device Business Decisions

A Quality management team reviewing documents in a conference room

Nadia Ragnvald Caspersen Senior consultant, Medical Device QA – GBA Key2Compliance When it comes to ensuring the safety, effectiveness, and regulatory compliance of medical devices, quality management cannot be left as an afterthought. Business decisions, from the early stages of development to the final stages of manufacturing, must be driven by a commitment to quality. […]

The Crucial Role of Management in Quality for the Medical Device Industry

A Quality management team reviewing documents in a conference room

Nadia Ragnvald Caspersen Senior consultant, Medical Device QA – GBA Key2Compliance In the highly regulated medical device industry, quality is not just a checkbox—it is a cornerstone of successful business operations. The importance of quality management in this field cannot be overstated, as it plays a vital role in ensuring product safety, regulatory compliance, and […]

Fusion of AI and Medical Devices- A Free webinar presented by BSI and GBA Key2Compliance

Fusion of AI and Medical Devices, Free webinar by GBA Key2Compliance and BSI, January 31st

We’re excited to partner with Notified Body BSI! Thomas Doerge from BSI, along with our GBA Key2Compliance experts Azadeh Hajipour and Stina Gustafsson, will lead discussions on the challenges of proper control and effectively managing changes within the MedTech sector. As medical device manufacturers, you’re at the cutting edge of technology, balancing innovation with compliance. […]

5 most common misconceptions about biocompatibility 

A lab technician handles a sample tube

Kristina FantDirector, Biological Safety – GBA Key2Compliance For any device that comes in contact with either a patient or a user, it is crucial to assess possible biological risks early in the development process. However, there are a lot of misunderstandings that we commonly encounter in our daily work with different medical device manufacturers. See […]

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