Quality and Compliance for ATMPs – A Strategic Enabler for Patient Access
Afifa Trad Senior consultant, Pharma QA – GBA Key2Compliance Advanced Therapy Medicinal Products (ATMPs) are transforming the treatment landscape for complex and previously untreatable diseases. By leveraging gene therapy, cell-based treatments, and tissue engineering, these therapies offer truly personalized solutions. But with innovation comes complexity—and success depends on one key factor: a robust strategy for […]
Strengthening MDR Compliance Through Literature Search
Johanna Fugelstad and Anna Sahlholm, Clinical Development, GBA Key2Compliance It is not uncommon that manufacturers think of the required structured literature search as yet another checkbox and that it is performed very late in the process of finalizing the technical documentation. Or it is performed once and never updated. Thinking ahead, the literature search can […]
How Strategic Knowledge Management Can Future-Proof Your GxP Organization
Afifa Trad and Evelina Philipson, Pharma QA Consulting and Training, GBA Key2Compliance In highly regulated GxP environments, knowledge is power. Strategic knowledge management is a critical foundation for life science organizations aiming to remain audit-ready, drive continuous improvement, and reduce operational risk. At GBA Key2Compliance, we believe that real change starts when the right people have […]
Medical Device Classification Under MDR & IVDR: What Manufacturers Need to Know
Why Medical Device Classification Matters If you’re a medical device or in vitro diagnostic (IVD) manufacturer, one of the first regulatory hurdles you’ll face is classification. This might sound like a technicality, but getting it right is crucial—it determines how much regulatory oversight your product needs, how long it will take to get to market, […]
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 […]