Arya Panda
Learning / / Page 2
Learning / / Page 2
The CE mark is required for all products sold on the European Union market. The European Union and an authorized representative of the EU approved the EU-2017/745[1] medical device rule on April 5, 2017, to address gaps and enhance the security, effectiveness, and efficiency of medical devices sold in the EU. A medical gadget needs […]
You might utilize aesthetic (cosmetic) devices to help get the desired result. However, there are hazards associated with using any device, even cosmetic devices, and a procedure may not always give you the results you want. The effects may also only last temporarily. Depending on their intended use and if they affect the structure or function […]
Notwithstanding its many difficulties, the import and export of medical devices remain a lucrative field. If a medical device can legitimately be marketed in the United States, it may be exported from the United States to any country in the world without previous FDA[1] notification or approval to export. This includes radiation-emitting electronic products that […]
A “management team” must be put together as you create your business plan, with careful consideration given to the essential positions that must be filled and the people who should hold them. Avoid taking the easy route by not appointing close friends and family members to important jobs just because of who they are. There […]
It also known as a residence certificate, is a legally binding document that can be used to establish residency in a specific State or Union Territory. This document, which is issued by the appropriate state government or UT administration, enables people to live in peace in their respective states and utilize all government services. Applicants […]
In India, there is a significant history of industrial classification. It is frequently used in business surveys, censuses, and estimates of national income, labor statistics, and other areas. In the early years, a variety of industrial classifications were used by organizations tasked with gathering statistical data. As a result, there was a pressing need for India […]
According to ISO 13485:2016, a Quality Management System[1] (QMS) must meet certain criteria in order to produce medical devices that are compliant with applicable regulations and client needs. Requirements of ISO 13485:2016 are applicable to companies regardless of their size and regardless of their nature, except when explicitly mentioned. While requirements are mentioned as being […]
One of the most popular categories of medical devices by sales is cardiology equipment. They are only surpassed by in-vitro diagnostic tools. Cardiology devices make up about one in ten medical devices produced. These might be small, implantable devices or huge, external machines, and they are all used to diagnose and treat cardiovascular issues, including […]
In the more than ten years that the medical device manufacturing sector has existed, software and technology have spurred a growing emphasis on design and simplicity. Moreover, innovation helped the medical device industry gain dominance over the pharmaceutical sector. Modern technologically advanced, user-friendly devices are still in high demand, and their time to market is […]
Companies have been able to develop devices that give better treatments, more accurate diagnoses, advanced data reporting capabilities, and overall better patient monitoring thanks to technological advancements in and around the medical device business. Sadly, these quick improvements have also given rise to brand-new, difficult security vulnerabilities for the medical device sector. Several business experts […]
Medical Device Coordination Group published instructions for designation, reassessment notification, and notified bodies. This will assist the authorities to approve applications for medical devices and in vitro diagnostic organizations. The goal is to harmonize and bring consistency to the various designating agencies’ operational procedures. The process of adding a notified body to the NANDO database, […]
On January 31, 2020, the UK formally left the EU. The post-Brexit transition period ended on January 1, 2021. Medical device firms with products in the UK market now need to plan for how they will obtain a UK Conformity Assessment. Medical devices now sold in the UK can continue displaying the CE mark, which […]
A clean room for medical devices is created and maintained so that no dust, bacteria, or contaminants can enter. To keep dust from entering, clean room for medical devices are typically pressured. Air pumps or fans pressurize the space by pumping air through a filter. The air leaves the room rather than being drawn in […]
Artificial intelligence, also known as AI, is a technology that is regarded as being transformative in the digital world and is currently adding value to the medical device industry. New regulations established by regulators, such as the Medical Device Regulation (MDR), In Vitro Medical Device Regulation (IVDR), and U.S. Food and Drug Administration (FDA), require […]
