The Importance of a Quality Management System (QMS) for Your Medical Device

Quality Management Systems QMS

Pär NeidenströmSenior consultant, Medical Device QA Dalia RhmanProduct manager PRRC, Medical Device QA The purpose of this article is to highlight the crucial role of the quality management system (QMS) for medical devices. Mainly by maintaining and improving patient safety and the product quality of the medical devices that are manufactured today. Of course, a […]

Fundamentals of the technical documentation

Technical documentation

Anna SzczepkowskaConsultant, Medical Device QA Introduction Technical documentation, also known as technical file, is a set of the documents that contains all the technical information concerning a medical device. Therefore, every EU manufacturer of medical devices (regardless of risk class) must according to regulations create technical documentation. This must include clear information regarding design, manufacture, […]

Expanding Your Medical Device Markets Globally: Smart Growth

Expanding Your Medical Device Markets Globally

Joanna JacksonSenior consultant, Regulatory Affairs Julia SelmaniSenior consultant, Regulatory Affairs Many businesses aim to expand and diversify their medical device markets to generate additional revenue while spreading risk. Despite the global regulatory environment for medical devices being diverse and complex, opportunities for expansion exist. However, if managed incorrectly, this expansion can lead to costly administrative […]

A detailed examination of Laboratory-Developed Tests (LDTs) and In-House Devices

Zahra Madijahn Consultant, 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 […]

Usability Documentation for Your Medical Device

Usability documentation

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

IEC 60601 Electrical safety regulatory compliance

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

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 […]

Compliance Expert Insights on IVDR: Understanding the Impact

In-Vitro diagnostics

With the new In Vitro Diagnostic Medical Device Regulation (IVDR) in place, IVD manufacturers are now subject to much more stringent regulatory requirements and processes, especially when compared to the previous In Vitro Diagnostic Medical Device Directive (IVDD). These new regulations first became effective in 2017 to address key issues identified with the previous regulations. […]

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 […]