For the most part, everyone in the medical device industry is familiar with the term “510(k)”, but not many people know that there are three different types of the premarket notification. The following are the different types of 510(k)’s a...
FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) released a list of regulatory science tools to help the industry in new product development. The Office of Science and Engineering Labs is a part...
As FDA begins to restart on-site inspections of domestic and foreign sites, Health Canada on the other hand has all of its on-site domestic and foreign inspections for drug good manufacturing practices postponed until further notice.1 However, Health Canada is using...
With the recent pandemic, one of the most crucial medical services is that of Digital Medicine. It is the merger of the medical device, pharma industries, and modern technology to better track and understand the physiological systems along with the...
Internal audits are a critical activity for every medical device firm. Not only are they mandatory per 21 CFR 820.22 and Clause 8.2.4 of ISO 13485:2016, but they are also fundamental in ensuring continuous review and improvement of a quality...
Hand sanitizers in Canada are regulated by the Natural and Non-Prescription Health Products Directorate (NNHPD). When the pandemic was at its peak, NNHPD released an interim guidance for expedited approval of hand sanitizers to help mitigate supply shortages. The expedited...
One of the widely accepted software design patterns is the Waterfall model in which all activities, starting from requirement gathering until the deployment are followed sequentially. It uses clear structures, transforms information well, and targets concrete goals. Even though it...
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) is taking big steps to deal with the pandemic during the ongoing 11 months transition period granted for its hard exit from the EU. As part of its preparation, UK’s MHRA...
One of the backbones of the current Industry 4.0 is Artificial Intelligence (AI). It is the process of simulating human intelligence in machines such as learning and problem-solving. Machine Learning (ML) forms a subset of AI and it provides the...
Medical Device user fees are something all medical device firms should be well acquainted with. Under the user fee system, medical device companies must pay fees to the FDA when they register their establishments and list their devices. Additionally, there...