Risk management is one of the most important parts of the manufacturing process when it comes to developing safe, effective, and beneficial medical devices. Your company needs to implement risk management at all levels in [...]

Regulatory inspections from the FDA are often nerve-wracking for a manufacturing company and its employees. An inspection can come along at any time, which is why you must be fully prepared for the possibility in [...]

New legislation was introduced in January of 2015 which seeks to change the way a new drug will be defined and, eventually, the amount of manufacturers interested in creating combination drugs. As a combination manufacturer, [...]

In January 2015 the FDA issued a new draft  guidance document regarding the final rule on current good manufacturing practice requirements (cGMP) for combination products that was issued on January 22, 2013 and made effective [...]

For medical manufacturers, compliance with the FDA regulations is paramount, as the device or product itself as well as the manufacturing process must all meet these specific standards. With the rise in mobile medical apps [...]

Biomanufacturing is a difficult process, as anyone who works in the field understands, and there continues to be a great need for the work of biomanufacturing to become less expensive, more streamlined, and all around [...]