Setting Strategic Direction for Medical Devices: The Role of Quality Management

A Quality management team reviewing information on a computer screen

Nadia Ragnvald Caspersen Senior consultant, Medical Device QA – GBA Key2Compliance For companies seeking success in the highly regulated medical device market, setting a strategic direction that emphasizes quality management is a non-negotiable requirement. A well-planned quality management strategy can streamline regulatory compliance, foster innovation, and enhance operational efficiency. Companies that prioritize quality as a […]

Ownership and Accountability in Medical Device Quality Management

A Quality management team meeting in a conference room

Nadia Ragnvald Caspersen Senior consultant, Medical Device QA – GBA Key2Compliance Accountability and ownership are critical for maintaining high standards of quality in any organization. In the medical device sector, where patient safety is paramount, these elements become even more vital. Effective quality management depends on leaders, teams, and individuals who understand their roles and […]

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. […]

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. […]

GBA GROUP at MEDICA 2024

Meet us at Medica 2024 in Dusseldorf, 11-14 november 2024

Meet our experts from GBA Key2Compliance, GBA MDS, and BAAT Medical at the upcoming MEDICA 2024, one of the largest medical B2B trade fairs in the world, from November 11th to November 14th in Düsseldorf, Germany. Join us in Hall 1 at booth 1D35 to explore new innovations and discuss how we can support your […]

The Importance of Establishing Safe and Efficient Sterilization Processes of Medical Devices

Packing line with surgery equipment sets prepared for sterilization

In the medical-device industry, sterilization refers to the process of eliminating forms of bacteria, viruses, fungi, as well as spores from medical devices and instruments. This step helps in ensuring that devices that come in contact with a patient’s body, during surgery or even during routine care, are free from microorganisms that may cause infections. […]

What is a MedTech CRO and how can it benefit your company?

2 persons in a laboratory, writing on a whiteboard

Jeanette DemorneyDirector, Clinical Development – GBA Key2Compliance Ever wondered how a MedTech Contract Research Organization (CRO) like GBA Key2Compliance can streamline your journey in the medical device and In Vitro Diagnostic (IVD) landscape? Let’s dive into how our critical support during clinical evaluation and strategic development can propel your project towards success. Understanding the Terminology […]

FINAL CALL: Only 6 Days Left! Join us for the Medical Device Product Life Cycle Conference

Medical Device Product Life Cycle Conference 8-9 october 2024, Stockholm - FINAL CALL

Don’t miss our international conference tailored to navigating the complexities of medical device regulations and standards. Why Attend? Gain invaluable knowledge from top industry leaders who will simplify complex processes and provide essential tools for success. Whether you’re in Quality, Regulatory, Design & Development, Clinical/Performance Evaluations, or Post-Market Surveillance, this conference is essential for staying […]

Join Us at NLS Days on September 18-19!

We’re excited to announce that GBA Key2Compliance will be attending NLS Days in Malmö next week. Visit us at booth B:07 to meet our team: Jan Hellqvist, Helena Dahlin, Jeanette Demorney, Terese Hedin, and Anders Jeppsson from GBA Key2Compliance, as well as Timo Lebold and Judith Richstein from GBA MDS. We look forward to connecting […]

Meet our new Director of Sales – Anders Jeppsson

We are delighted to welcome Anders Jeppsson as our new Director of Sales at GBA Key2Compliance. With over two decades of experience in the Life Science market, Anders brings a wealth of knowledge and a fresh perspective to our team. During his first week, we had the opportunity to sit down with Anders and ask […]

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