With the crossing of President Biden's 100th day in office, the administration still hasn’t nominated an FDA commissioner candidate, a delay that daily weakens the FDA and undermines the agency’s ability to act boldly and decisively in order to face the challenges caused by the pandemic and its aftermath. This article makes the case for what traits we need to see in an FDA leader and who would fit the bill.
The ICH 31000 guidance defines a risk as the “impact of uncertainty on objectives.” As a follow-up to his article on why we should replace the RPN with the adjusted risk likelihood (ARL), Mark Witcher describes how system risk structures can be used to simultaneously understand and manage both risks and benefits.
Dental 3D printers have experienced a surge in popularity in recent years, reflecting the increasing range of applications and opportunity for revenue generation offered by these systems. How does this market look for 2021, and what is the one dental device disrupting the market?
This article explores how medtech companies should approach the reimbursement pathway for their devices when seeking to enter the German market. By understanding the strengths and challenges of Germany's NUB process, you'll have a better understanding of how to navigate it.
Key Considerations For Selecting A Medical Pump
Newcomers to medical device design may think that pressure and flow rate are sufficient parameters to consider when it comes to selecting a pump. While this may be the case in some industrial applications, medical device requirements are a bit more demanding. A thorough review of the selection criteria for a medical pump is required to ensure the correct pump is chosen for every application.
Using medical-grade silicone offers a number of benefits for medical components, including meeting FDA regulations, superior gas permeability, excellent bonding and overmolding capabilities, as well as high flexibility and tear resistance.
Medbio offers a number of tips to follow for a successful startup in designing and producing injection-molded parts.
Injection molding has numerous key parameters that must tie together in order to make a repeatable molding process. Medbio offers a solution that utilizes cavity pressure curves, key process parameter tolerances, and automation to automatically reject parts that do not make the cut in in the molding process.
Vaccines and other large-molecule products require unique storage conditions, especially during the cold chain. Helium detection technology can improve the quality of drug delivery system and container design.
MED DEVICE ONLINE CONTENT COLLECTIONS
This e-book is a compilation of various statistically based techniques to help determine risk-based sample sizes to support process validation activities. It is intended to aid the practitioner avoid regulatory compliance issues. Each technique provides the context for its application, formula(s), variables, and a fully worked example to help understand and apply the technique.More Content Collections