Medical Device Adverse Event Reporting Systems in EU, Canada and US

Medical device firms’ obligation doesn’t end upon obtaining a marketing clearance, approval, or certificates. Medical device manufacturers are required to report adverse events to the authorities (e.g., Competent Authorities, Health Canada and US FDA), where applicable. To achieve compliance and to remain compliant with the adverse event reporting requirements, it is imperative that medical device manufacturers […]

With Macy Foundation Grant, Drexel Teams with 12 Institutions to Enhance Professionalism in Medical Education

The Josiah Macy Jr. Foundation has awarded a grant to Drexel University faculty to support the dissemination and enhancement of an online resource for teaching future health care providers about professionalism in medicine — including empathy, compassion, honesty, ethics and social justice. Dennis Novack, MD, associate dean of medical education at the College of Medicine, […]

Psychiatric care is postcode lottery, say medical experts

There are not enough NHS psychiatrists in some parts of the UK and more should be recruited to improve care, says the Royal College of Psychiatrists. In Scotland, there are 10 consultant psychiatrists per 100,000 people – but only eight for the same number in England and Northern Ireland, and just six in Wales. London’s […]

The Ultimate Guide To Design Controls For Medical Device Startups

    What’s this guide about anyway? Back in 1998, I started my career as a medical device product development engineer. At that time the FDA Design Controls regulations were still fairly new — not only to me — but the industry in general. In those days, we all struggled to understand how and what […]

Medical device companies need to get their design controls right

Design controls are among the most frequently cited areas for 483 and Warning Letter observations from the FDA, despite the regulatory agency considering this area as critical. It goes without saying that Design Controls are indispensable for ensuring the safety and effectiveness in the production of medical devices. Statistics show that a substantial percentage of […]

Statistics for Medical Professionals

Medical statistics, also called biostatistics, is an important area for medical professionals. Statistics and the medical professionals may not seem very easily associable with each other at first glance, but a deeper look suggests the connection between statistics and the medical profession. Statistics is a set of data and tables. These figures are meant to […]

GlobalCompliancePanel Professional Training and Development Courses with Flat 50% OFF on all Seminars

Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a […]

GMPs for API Bulk Manufacturers

Till recently, till 2001 that is, Good Manufacturing Practices for Active Pharmaceutical Ingredients (APIs) bulk manufacturers was carrying a bulky load on its shoulders, so to speak. GMP for active pharmaceutical ingredients (APIs) per se had no independent guidelines. The GMPs that they were to follow and implement were bunched with those of APIs for […]

Applying ISO 14971 and IEC 62304 to medical device software

Risk management of software used in medical devices has to be implemented diligently, completely and correctly, scrutinizing the gaps thoroughly and correcting them right from the very start of product development. This is critical because of the following reasons: Medical products that have gaps or are implemented incorrectly or incompletely suffer serious ailments such as […]

Supplier Management Conference for Medical Device Manufacturing in HONG KONG

  Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect […]