A detailed examination of Laboratory-Developed Tests (LDTs) and In-House Devices
Zahra MadijahnConsultant, Regulatory Affairs The Power of Precision Medicine Laboratory-developed tests (LDTs), generally known as in-house devices, play a crucial role in diagnostic laboratories worldwide. Although both in-house devices and LDTs are created and utilized within a healthcare facility, the term “LDT” is generally used in a more specific context to refer to tests made […]
Usability Documentation for Your Medical Device
Malin TruvéRegulatory Affairs consultant, Usability expert Are you about to perform a Usability evaluation for your medical device and are unsure of what usability documentation that are needed? There are three common mistakes that a lot of people make. This blog to help you avoid some of the pitfalls. The advice is based on fulfilment of […]
IEC 60601 – Meeting the Electrical Safety Standards of Medical Devices
Read and learn more about IEC 60601 and IEC 61010, and the factors you should consider when developing a regulatory-compliant medical device. Electrical devices are part of our everyday lives, and they are undoubtedly cornerstones of our society and technology – this applies to the industries of life sciences and medical technology as well. However, […]
Borderline Medical Devices
Olivia SunSenior Consultant Regulatory Affairs Have you ever been unsure of whether or not the device you are working with is a medical device? Don’t worry, most of us have. Medical devices are based on a wide spectrum of technologies. In fact, there are about 2 million different kinds of medical devices on the world […]
The Importance of Understanding Medical Device Classification
In the process of putting a medical device or an IVD product on the market, one of the first and most important steps is correctly identifying its risk classification. In a nutshell, medical device classification is a regulatory process used in categorizing medical devices based on their intended use, as well as potential risks to […]
IVDR – Overcoming challenges while establishing Regulatory strategy
By Julia Selmani Regulatory Affairs specialist, Key2Compliance AB Establishing a strategy for regulatory compliance for your company is a new IVDR requirement, defined in Article 10(8a) where the aspects to be addressed by manufacturer’s QMS are listed. Thought ISO 13485 does not explicitly include requirement for Regulatory strategy, it includes the requirement to incorporate regulatory […]