According to the FDA, more than 90% of products sterilized at the facility are medical devices.
Healthcare facilities need to make sure they have enough personnel and equipment that can manage device reprocessing.
10 factors design engineers must consider when creating stick-to-skin medical devices.
Reusable devices have become more difficult to clean, disinfect and sterilize. FDA is now requiring clear instructions for effective reprocessing.
The deal creates the largest global sterilization and lab services operation.
Complexity of design and frequency of use play a large role in how effectively scopes are reprocessed.
Part three of the design verification series discusses in detail the steps that should be taken during testing.
Prior to design verification of packaged products, consider the following process-related elements.
The way in which we deliver healthcare is changing rapidly. Technology and rapid adoption is enabling device and tech manufacturers to develop products that move the delivery of care away from the clinical environment. Having the option to stay out of hospitals could be extremely important from both a financial standpoint as well as a health perspective, and could essentially help low-risk patients avoid exposure to viruses. Our experts today provide information regarding the regulatory requirements for …
This week’s guidance is all about the manufacturing control of sterile medical devices, validation, and more validation.