The UKCA (United Kingdom Conformity Assessed) marking is a product marking dedicated to products placed on the Britain markets (i.e., in England, Scotland, and Wales). The UKCA marking covers the following products: Aerosols Ecodesign Equipment for outdoor use Equipment for potentially explosive atmospheres (UKEX) Electromagnetic compatibility Gas appliances Lifts Low voltage electrical equipment Machinery Measuring […]
What is Control Strategy? A control strategy is comprehended as a planned set of controls derived from the understanding of process and product while assuring the product’s performance, process, and quality. The control strategy begins with understanding the product and process. In general, a control strategy comprises the following components:• Composition materials• Components• Constituent parts• […]
With its implementation, EU MDR has put forth a lot of new requirements for medical device manufacturers. One of these requirements concerns the manufacturers trying to get a CE mark for their devices. These requirements are set forward by GSPR, or General Safety Performance Requirements. What is GSPR? GSPR is a set of requirements in […]
Since there are 24 official languages in Europe, there is a need to translate information given on the labels into different languages. By using symbols as an alternative to written languages, these requirements can be met easily. In its Annex I, chapter III, 23.1.h., MDR has permitted the manufacturers to use the symbols in the […]
IoT or the Internet of Medical Things can be defined as a suite of medical devices and applications connected to the internet to allow real-time, rapid, and dynamic analysis. Trends on Internet of Medical Things Research from Deloitte UK’s center indicates that the IoMT market is projected to grow by $160 billion by 2022. This […]
ISO standards belong to different categories. Some of these standards are industry-specific, while others are generic and can be applied to any industry. Among these, the most popular ISO standards are: ISO 9001 ISO 9001 is among the most popular ISO standards belonging to the ISO 9000 family, a family of quality management standards. Although […]
The UK House of Commons had introduced its Medicines and Medical Devices Act last year. This year, the bill got confirmation and has been passed as a law. This bill is primarily centred on the patient’s safety, a concern that has been raised in EU MDR and EU IVDR as well. This bill also discusses […]
With the technological advances, medical device manufacturers are now considering eIFUs (electronic Instructions for Use) as replacements for paper IFUs. Why are eIFUs needed? eIFUs are required to cope with the extensive digitalization in the modern world. In reality, using eIFUs provides medical device manufacturing companies with many benefits compared to their paper counterparts. Some […]
Foreign manufacturers willing to place their products on the Swiss medical device market must appoint a Swiss Authorized Representative. Before selecting the Swiss Authorized Representative, an agreement must be made between the manufacturer and the Representative. Need of the Authorized Representative A bilateral agreement between Switzerland and the European Union allows mutual recognition of conformity […]
Environmental pollution and global warming are some of the most concerning issues of the modern world. The indoor air quality is also affected by outdoor environmental issues. As a result, many standards have been devised globally to manage air pollution, and ISO 14644 is one of them but it focuses on indoor air quality. ISO […]