Notice to companies in Massachusetts: RQMIS offers the following highly rated courses:
We are a certified Supplier with the State of Mass. This allows those interested in this training for themselves or their employees, to apply for a grant through the Mass. Dept. of Workforce Development. Please visit the Mass. Gov. websites below for grant details.
Express Grant link:
Training Pro link:
Interested in labeling compliance and mobile medical applications? RQMIS will be presenting on these topics on October 28th – 30th at the Maritim Hotel in Berlin, Germany. We hope you will join us!
Please click on the links below for more information.
Conference Hotel: http://www.maritim.com/en/hotels/germany/hotel-berlin/hotel-overview
An idea for a new medical product can arise from a breakthrough in technology (smart phone technology/the cloud, a new biomaterial, nanotechnology, etc.), the identification of a new compound that can interact with a biological process, the ability to manufacture a biological molecule (e.g, peptides, the ability to process human tissue to derive active biological substances (e.g., stem cells) or combining medical devices with biologics or drugs. However, none of these intriguing or exciting breakthroughs will achieve commercial success without a clear connection with an unmet patient or clinical need. These needs can already be in demand by clinicians (a product to monitor patients remotely) and surgeons (an artificial spinal disc that restores motion to the spine). Or the need that may not be appreciated until the technology presents the opportunity (nanotechnology that allows selective uptake of drugs based upon cell type).
These breakthroughs in technology may create new medical products or they may allow existing products to be modified to improve performance, including safety and/or effectiveness. Regulatory bodies dictate the pathway to first human use and ultimately commercial use of these medical products. Insurance reimbursement entities influence the development of products due to reimbursement decisions. Every country has its own pathway, but the medical products indication for use/intended use and its mechanism of action or mode of action play the primary variables in defining the regulatory pathway’s complexity.