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Startup

Medical product start-ups need to minimize regulatory and compliance risk to attract early-stage investors and save money. To make matters even more complicated, recent changes in IRS and SEC regulations make it more important than ever to limit potential liabilities to avoid adverse valuations that can affect a start-up’s bottom line and ultimate success.

Entrepreneurial Start-up AssistanceStart controls too early and you may stifle ingenuity. Start too late and you will add unnecessary costs and waste time. We’ve helped a wide range of pre-revenue start-up companies develop effective quality assurance and regulatory compliance strategies to obtain FDA and ISO clearances. We will work with you to develop a quality system appropriate to the complexity and growth stage of your company.

Many companies try to buy their way into compliance by purchasing a quality system online. These systems may be inexpensive, but they introduce very costly and time consuming quality requirements. Let us review your system before you purchase anything. We may be able to develop a less expensive, less rigorous quality system that will meet your exact needs, reducing complexity and bureaucracy and saving you both money and time.

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The Latest News

FDA Inspection? We Can Help You Relax.

Nothing can strike fear into the heart of a medical device manufacturer quite like an unexpected notice from the FDA. How you prepare for an FDA inspection? What is the process? What are they going to look for? Are they really that mean? After the inspection how do you respond to a 483 notice or worse what happens if you received a warning letter? How you perform during the inspection can make all the difference in the world between a quick resolution and a long expensive remediation program....
MEDIcept

Validating Medical Devices

One of the cornerstones of medical device manufacturing is the ability to efficiently and cost-effectively validate medical devices to ensure FDA compliance and to successfully and profitably bring medical products to market. Proper validation is a core requirement for any medical device manufacturer looking to achieve regulatory agency compliance and sell their products domestically and internationally. At MEDIcept, we understand that medical device testing is a rigorous and complex process...

We are state-of-the-art in the validation process

US Food and Drug Administration (FDA) and international regulatory standards continue to evolve and become more stringent as medical devices become more complex in design, functionality, and technological integration. This makes the process of medical device validation and verification even more important—not only to comply with regulations, but also to aid in the design of the highest-quality components and the production process. The desired result is better repeatability, fewer mistakes,...