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 […]

An understanding of Risk Management and Analysis for Medical Device Manufacturers

Risk management and analysis for medical device manufacturers is an essential set of approaches to quality in the field of medical devices. Implementing these is of absolute importance and criticality to the field, as the products in this industry are high-specialty ones that deal with human lives. A small error at any stage can send […]

Good Manufacturing Practices are essential for ensuring quality

Good Manufacturing Practices (GMPs) constitute one of the core components that go into the manufacture and distribution of foods, drugs and other pharmaceutical products. Good Manufacturing Practices are prescribed by regulatory agencies from around the world, the FDA and the EMA being among them. The guidelines set out by these regulatory agencies are aimed at […]

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, […]

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 […]

An integrated approach is needed for Complaints Handling, Adverse Event Reporting, and Recalls

Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2016 emphasizes this problem

Marketing and promotion of drugs and medical devices

Regulation of the promotional aspects of prescription drugs, biologics, medical devices and biotechnology products with the intention of ensuring

Good Manufacturing Practices are essential for ensuring quality

Key Takeaway: GMPs are critical for the manufacture and distribution of foods, drugs and other pharmaceutical products. These need to be implemented diligently by organizations that are involved in these products. Quality is a great concern for a manufacturer and consumer of any product. To ensure that quality is maintained across a variety of products […]