MEDIcept strives to provide our clients with proven, trusted, and cost-effective solutions. With decades of combined experience in the global medical device industry, we are uniquely qualified to help you navigate complex regulatory pathways, reducing your business risk and time-to-market, while maximizing your potential for success. Have you received a 483 notice or a warning letter? Is your ISO certificate or CE Mark in jeopardy? We can help you respond quickly and effectively to prevent a difficult situation from getting worse.
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Are you creating engineering documentation twice? Once during design and development and a second time when you compile information for your regulatory submission? Our team of experienced engineers can help with the development of the mechanical, electromechanical, and software documentation required to successfully create a Design History File and support a regulatory submission or technical file. We don't just have the engineering knowledge; we also know what the FDA and Notified Bodies will be looking for in a submission.
Every new medical device or drug is confronted by obstacles-and opportunities-posed by the United States' unique and complex system of health care finance and insurance. The more innovative the product, the greater the opportunities and obstacles. Among the keys to commercial viability and success, every entrepreneurial company needs to:.
If you manufacture a medical or in vitro diagnostic device, emergencies happen. The FDA can inspect you at any time with very little or no notice. An adverse event can occur. How prepared you are can differentiate between an efficient and cost-effective response and a prolonged, expensive struggle to resolve the problem.
With everything from cars to pacemakers now susceptible to cyberattack, questions about how safe our data is have come to the forefront. The Food and Drug Administration (FDA) is one of the organizations taking these concerns seriously, working to ensure that medical devices are secure against potential cyber threats.
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