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 […]
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 […]
The Importance of Establishing Safe and Efficient Sterilization Processes of Medical Devices
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. […]
Research Use Only (RUO) vs. Device for Performance Study
Zahra MavajianRegulatory affairs specialist – GBA Key2Compliance AB Disclaimer: This article is provided for informational purposes only and should not be considered official text. Always check and follow applicable local rules and regulations. Startups in the medical device or in vitro diagnostic (IVD) sectors often face challenges in obtaining regulatory approvals quickly, whether it be […]
The Important Role of a PRRC in Medical Device and Software Compliance
One of the changes introduced by the Medical Device Regulation (MDR) in 2017 and the In Vitro Diagnostic Device Regulation (IVDR), is the requirement of a designated Person Responsible for Regulatory Compliance (PRRC). A PRRC bears the important role mandated by the MDR and IVDR of maintaining the safety, integrity, quality, and effectiveness of medical devices. […]
Good Manufacturing Practice: Preparing for GMP Inspections and Addressing Common Challenges
Before going into the specifics of how pharmaceutical manufacturers can better navigate Good Manufacturing Practices (GMP) inspections, having a baseline understanding of GMP will help in properly preparing for inspections and avoiding common pitfalls. Simply put, GMP is a regulatory set of best practices that has been developed over time to ensure that products are […]
What is a MedTech CRO and how can it benefit your company?
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 […]
The New IVDR Timeline: The European Commission’s 2024 Proposal
Zahra MavajianRegulatory affairs consultant The European Commission has recently proposed an extension to the transition periods for certain In Vitro Diagnostic (IVD) devices. This proposal, published in January 2024, is a significant development in the field of medical devices and patient safety since it provides more time both to manufacturers and the notified bodies to […]