THANK YOU FOR SUBSCRIBING
Digital transformation can significantly affect medical device design, manufacturing, and sales.
FREMONT, CA: There are a few industries that evolve as rapidly as healthcare and medical device manufacturing. Digital transformation, technological advances, healthcare reform, and regulatory compliance issues can substantially affect medical device design, manufacturing, and sales. It is no wonder that medical device manufacturers are massively turning to consultants for help.
The medical device development process is a complicated one with twists and turns, leading to unexpected and costly delays. Every reviewer is looking for something different. Submission deliverable needs to keep changing. An experienced medical device consultant fully understands the FDA submission process for 510(k)s and premarket approvals (PMAs)and can help craft a regulatory strategy based on its needs. With the right help, one can optimize their submissions to save money, time, and effort.
Minimize the risk through crisis intervention
As far as medical device manufacturers, the rewards can be great, but so can the risks. FDA warning letters, product recalls all pose a significant risk to a company and its future.
The right medical device consultant can help prepare and respond to a wide range of potential crises before they spin out of control and result in criminal or civil actions, substantial fines or other financial penalties, and even the business’s shut-down. An experienced medical device consultant can assist in responding to an FDA audit or warning letter to effectively prepare a strategic response and proactive plan to address their concerns.
A medical device consultant can help the customers to identify options, take very corrective actions, and create a response to the FDA.
Expand the market
The world is shrinking, and even modest-sized device manufacturers are expanding globally to compete. Suppose companies are looking to Europe as the next market for their medical devices. In that case, MEDIcept’s international experience can assist with the European Community’s needs for receiving the CE Mark necessary for selling the medical devices there. Presently, this entails complying with possibly three kinds of directives: the In-Vitro Diagnostic Directive (IVDD), Medical Device Directive (MDD), and Active Implantable Medical Device Directive (AIMDD). Very soon, the new Medical Device Regulation (MDR) and the new In-Vitro Diagnostic Regulation (IVDR) will be needed, which means significant changes to the way products are approved in Europe. An experienced European market medical device consultant can help with device classification, selecting a certifying body, and preparing technical files.