Few industries evolve as rapidly as healthcare and medical device manufacturing. Digital transformation, healthcare reform, technological advances, and regulatory compliance issues can all significantly affect medical device design, manufacturing, and sales. It’s no wonder medical device manufacturers are increasingly turning to consultants for help.
If you’re a medical device equipment manufacturer considering hiring outside assistance for your next product or to address a looming compliance issue, here are three major reasons why turning to MEDIcept:
- Streamline FDA regulatory approval
The medical device development process is a complex one with twists and turns that can cause unexpected and costly delays. Every reviewer is looking for something different. Submission deliverable requirements keep changing. Our experienced medical device consultants fully understands the FDA submission process for 510(k)s and premarket approvals (PMAs)and can help craft a regulatory strategy based on your needs. With the right help, you can optimize your submissions to save time, money, and effort.
- Minimize risk through crisis intervention
For a medical device manufacturer the rewards can be great, but so can the risks. FDA warning letters, product recalls, all pose significant risk to your company and its future. Are you prepared to effectively manage a crisis?
The right medical device consultant can help you 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 shut-down of your business. An experienced medical device consultant can assist you in responding to an FDA audit or warning letter to help you effectively prepare a strategic response and proactive plan to address their concerns.
Perhaps you’ve discovered through a health hazard analysis that there’s an actual or potential problem with your device that could injure someone. How do you respond? Do you inform the FDA? A medical device consultant can help you identify options, take corrective actions, and formulate a response to the FDA.
- Expand your market
The world is getting smaller and even modest-sized device manufacturers are expanding globally to compete. If you’re looking to Europe as the next market for your medical devices, MEDIcept’s international experience can assist with European Community requirements for receiving the CE Mark necessary for selling medical devices there. Currently this entails complying with possibly three different directives: the Medical Device Directive (MDD), In-Vitro Diagnostic Directive (IVDD), and Active Implantable Medical Device Directive (AIMDD). Soon the new Medical Device Regulation (MDR) and the new In-Vitro Diagnostic Regulation (IVDR) will be required which mean significant changes to the way products are approved in Europe. An experienced European market medical device consultant is able to help you with device classification, selecting a certifying body, and preparing technical files.
These are just three compelling reasons why device manufacturers work with MEDIcept medical device consultants – there are a host of other regulatory, clinical services and quality assurance reasons to partner with an experienced consultant. To learn how your medical device company could benefit from third-party consulting, please contact the medical device specialists at MEDIcept.