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 […]

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 […]

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 […]

Medical products need to be validated for Radiation Sterilization

Do it right the first time” should be the mantra for medical device manufacturers that plan to make radiation products. Choosing the most functional and radiation resistant materials for their medical device will help them avoid the trouble of going through the post launch cycle of product revisions. To get this right, one simple line […]