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.
While the RPN primarily represents a risk event’s severity, perhaps a more important attribute to focus on is the risk event’s likelihood of occurrence. In this provocative article, Mark Witcher, Ph.D., proposes an adjusted risk likelihood rating approach that emphasizes a risk event’s likelihood of occurrence.
The transition to the U.K.’s new regulatory regime has officially begun as of Jan. 1, 2021. All medical devices on the U.K. market must be registered with the MHRA. Discover the 10 actions you should take to prepare for the U.K. Conformity Assessment process.
The first article in this two-part series covered details associated with economic operator responsibilities, overall QMS considerations, and common challenges during implementation of the EU’s Medical Device Regulation (MDR) and the EU’s In Vitro Device Regulation (IVDR). This article focuses on typical challenges experienced during the technical documentation assessments conducted by the notified bodies.
Why Use A Medical Grade Silicone For Your Component?
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.
Designing a product with consideration for the manufacturing process can reduce production times and costs, as well as simplify development of transport, storage, and protection solutions.
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