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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

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...

Medical Device Risk Management: An ISO14971 Update

In 2000, the first edition of ISO 14971 was released as the international standard for risk management of medical devices. This year, the ISO technical committee (ISO/TC 210) has been hard at work updating this globally-recognized standard. And while the fundamental stages of the risk management process remain unchanged, there are some key modifications that medical device manufacturers should be aware of to ensure that they can successfully navigate the development, testing, and launching of...