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The new EU MDR and the new IVDR have some harmonized standards also known as recognized standards. The harmonized standards are those that are referenced in the Official Journal of the European Union. Devices that comply with these harmonized standards...

The term “cosmeceutical” has become popular in recent years to describe a cosmetic product that claims medicinal benefits. While those in the cosmetic industry use the term to advertise the ingredients and benefits of their products, the FDA does not...

With FDA’s Food Safety and Modernization Act (FSMA), importers were given greater responsibility for ensuring that imported foods are safe. The Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is a program that requires importers...

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 U.S. Food and Drug Administration is offering another opportunity for stem cell clinics to work with the Agency and understand the regulatory framework. Will it work this time around? This blog article recaps how we got to this point. Stem...