Thanks to the rapid development of vaccines and quick vaccinations in major parts of the world, there seem positive developments in all the business sectors towards the growth. However, the threat is persisting in terms of new waves and new variants of COVID. Let us hope we soon get over this and see the brighter side of the business.
-
-
It is apparent that COVID-19 has permanently changed the ways of business operations for many industries across the globe. In fact, it has subtly given a renewed purpose to industries to evolve and advance in terms of tech-enabled and automated workflows.
-
December 20, 2021 Medical DevicesThe FDA’s CDRH (Center for Devices and Radiological Health) has published a list of medical devices guidance documents for the fiscal year 2022.
-
December 17, 2021 Medical DevicesA 510(k) submission for medical devices is a mandatory process to receive market clearance in the USA. While the submission process may not be onerous, figuring out where and how to begin can be daunting. However, the US FDA provides ample information in its guidance documents to assist the medical device manufacturers for a smooth 510(k) submission.
-
December 16, 2021 Medical DevicesIntending to curb the spread of COVID-19, the MHRA extended the free PPE (Personal Protective Equipment) scheme, which was initially introduced in March 2020. The scheme intends to protect the health and social care providers, and community pharmacies, and public sector organizations from COVID-19, by providing easy access to PPE in the volume required.
-
December 16, 2021 Medical DevicesSoftware and Artificial Intelligence (AI) play an important role in the medical device sector, with a fast-developing and wide set of applications in the health care system. Most of the applications will be regulated as medical devices and can range from screening to diagnosis to treatment and management of chronic conditions.
-
December 16, 2021 Medical DevicesOver the past few decades, the use of software has drastically advanced and brought about rapid changes in the medical device industry. The increasing importance of software in medical devices and the patient’s experience is crucial for further developments. However, SaMD has challenges for both regulators and the medical device industries alongside the new opportunities.
-
December 15, 2021 Regulatory Affairs, Publishing & Submissions, Health Authority UpdatesMarketing Authorization Holders (MAHs) in the United Kingdom were provided and asked to submit any/all data and related information for all converted licenses in the electronic Common Technical Document (eCTD) format within just one (01) year starting from January 01, 2021.
-
December 15, 2021 Pharmaceuticals, Registration Strategy, Market AccessSupply chain challenges across the globe have laid bare the inefficiencies of the distribution system framework amidst the pandemic. Considering its enduring impact on the global pharmaceutical market, better operational structure and resilient operational framework are the basis for seamless manufacturing requirements in hindsight.
-
December 10, 2021 Medical DevicesWith the development of technological advancements, there is an increase in the usage of network connection technology for medical devices. The connected medical devices store and transmit the patient data and demand both privacy and accuracy. Therefore, the cybersecurity of medical devices will continue to be in focus for regulators and manufacturers.