Setting Strategic Direction for Medical Devices: The Role of Quality Management
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
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
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
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 […]
5 most common misconceptions about biocompatibility
Kristina Fant Director, 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. […]
Safe Integration of Electrical Safety and Software in Medical Devices
Gustav SundströmSenior Consultant, Regulatory Affairs – GBA Key2Compliance The medical device industry holds patient safety as a top priority, but as devices grow increasingly complex, ensuring their safety demands more than just careful design—it requires a comprehensive approach. Today, medical devices rely heavily on both electrical safety mechanisms and medical device software (MDSW) to function […]
Join GBA Key2Compliance at Tema Renrum 2024 in Upplands Väsby!
We’re excited to share that GBA Key2Compliance will be attending Tema Renrum 2024 on November 26-27 in Upplands Väsby! For over 25 years, Tema Renrum has been the go-to event in the Nordics for cleanroom technology. Over two action-packed days, attendees will enjoy expert presentations, a bustling exhibition, and plenty of networking opportunities. Our experts, […]
GBA Key2Compliance assists Watson-Marlow Flexicon with QA Manager
“During a critical period for Flexicon, we received invaluable assistance from the consulting firm GBA Key2Compliance, as we were without a Quality Manager for three months. With her expertise, Nadia stepped in and handled everything from customer audits and complaints to inquiries from clients. This enabled us to maintain our high standards and ensure continuity […]
Proud Silver Sponsor at ATMP Sweden 2024 – Meet Us in Malmö!
We’re thrilled to announce that GBA Key2Compliance will be attending ATMP Sweden 2024 as a proud Silver Sponsor! Join us on November 25-26 in Malmö at Sweden’s premiere annual conference for ATMP stakeholders, ATMP Sweden, bringing together experts from pre-clinical research to reimbursement and standard of care. Our experts, Sara Falkenklint and Maria Axelsson, will […]
Device changes and how they may impact biocompatibility
Kristina Fant Director, Biological Safety – GBA Key2Compliance AB Medical devices will go through many changes throughout their product lifecycle, such as change of suppliers for raw materials, change of production site, or development in subsequent product generations where technical improvements are central. Impact on the biological safety Throughout these processes, it is crucial to […]