How does gene therapy fit into the FDA? Is it a medical device, a drug, or a combination product? What if gene therapy can cure a life-threatening disease? There are a lot of questions that can pop into your mind...
Are you looking to expand your consumer base and grow your business? International marketing is beneficial by creating long-term business relationships and increasing brand reputation. Expanding your market to a country like Australia is a smart commercial move, but how...
Whenever there is a public health emergency, such as the Zika virus in 2016 or the current novel coronavirus, there is a rush to get diagnostic tests and other medical products to detect and treat the emergency available quickly. Given...
The transition to the new EU MDR and IVDR tops the list this year with the concerns and confusion it continues to create within the industry. With a limited number of guidance documents to guide the device makers, companies are...
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...
Having a good CAPA management system is a key element in making sure your CAPA process is successful. QualiPro has the functionality to manage the entire CAPA process – even those CAPAs that originate in other systems. A request can be...
After the shutdown of a major contract sterilization facility in Illinois, and another one in line to close its doors soon, FDA is worried about a shortage of medical devices. Ethylene Oxide is a widely used sterilization technique for medical products...
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...