Regulatory

Clinical evidence is required to assure the safety and efficacy of a medical device for intended use pre-market. After an appropriate risk-benefit analysis, the device may still be placed on the market with the residual risk. The questions about residual...

The Food Safety and Modernization Act (FSMA) was signed into law in 2011, with compliance dates for some businesses beginning in 2016. However, because of the extent of reform, FDA is still working on providing guidance documents and tools that...

Colors can set apart your medical device, drug, food, and cosmetic. But, do you know how FDA permits their use within the US? This blog article reviews the regulations and processes in place for color additives. Color additives, artificial color, or...

The European Medicines Agency (EMA) and the United States FDA have fully implemented the Mutual Recognition Agreement beginning July 11, 2019. This agreement allows the European member states and the FDA to rely on each other’s GMP inspections of pharmaceutical...

ISO 14971 is the ultimate gold standard for risk management for medical devices. It was developed to provide manufacturers a process to assist in identifying the hazards associated with their devices, the health risks they possess and how to effectively...

Nonconforming products happen but managing them before they spin out of control is important. With QualiPro you can manage non-conforming products with ease. It easily tracks products through all phases of the nonconformance process: description, analysis, investigation, decision, closure, and...

The $40 billion dietary supplement industry is still growing making it a market you may want to take advantage of, but FDA’s oversight of these products is also increasing1. FDA currently regulates dietary supplements Under the Dietary Supplement Health and Education...

FDA has issued a proposed rule to up classify surgical staplers for internal use as class II medical devices, subject to special controls and pre-market notification. Currently, both internal and external surgical staplers are classified as class I, subject to...

Ensuring you have a robust Quality Management System (QMS) is the first step in maintaining compliance with both FDA and ISO regulations and requirements. A good software-based quality management system can make the process much easier. A paper-based or multi-software...

China is considered to be one of the many booming medical device markets with its continually increasing innovation potential and high market demand. In 2016, China’s medical device industry achieved a total sales revenue of 244.8 billion yuan, an increase...