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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 Updates Special 510(k) Guidance

FDA’s Special 510(k) submission process has been around for years as an expedited method to demonstrate that the device to be marketed is at least as safe and effective (i.e., substantially equivalent), to a legally-marketed device not subject to the Premarket Approval (PMA) process. In September 2019, a modified version of this program was published to create a streamlined review of technological changes made to a manufacturer’s own cleared device which leveraged design control requirements....

Metal Implants: FDA’s November, 2019 Immunology Devices Panel Meeting

The Immunology Devices Panel of the FDA’s Medical Device Advisory Committee met in November to discuss the topic of immunological responses to metal-containing products regulated as medical devices. The panel focused on metal-containing implants as well as dental amalgam. Recent post-market issues with some metal-on-metal orthopedic implants and gynecological metal-containing implants have raised questions about the potential for some patients to develop unexpected or heightened biological...

Quality Systems in Motion, Inc. (QSIM) is now part of MEDIcept Inc.

For Immediate Release Ashland, MA: MEDIcept Inc, an international quality, regulatory, and clinical consulting firm focused on medical device and in-vitro diagnostics (IVD), and QSIM, a US-based privately held consulting firm specializing in medical device/biotechnology, announces the merger of the two companies. QSIM, under the direction of Brian Markham, President, specialized in providing leadership and resources for organizations undergoing significant quality system change due to...