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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

Europe’s New Medical Devices Regulation: Ready or Not, Here It Comes

For the past 30 years, the European Union’s medical device market has been regulated by the Medical Devices Directive (MDD). The rapid development of hybrid technologies, tensions between EU member states, and highly bureaucratic procedures for resolving disputes made the text of the Medical Devices Directives seem obsolete much earlier than anticipated. As a result, the European Commission authorized the development of a new set of industry requirements known as the Medical Devices Regulation...

MEDIcept Now Offers CRO Services

November 14, 2019, Ashland, MA – MEDIcept Inc., a leading international Quality and Regulatory consulting firm focused on medical device and invitro diagnostics, and ACMP Consulting, Acton, MA have entered into an agreement to provide Clinical Research Organization (CRO) services for early phase, pre-, and post-market studies to the healthcare industry. The MEDIcept/ACMP agreement will offer medical device companies full clinical operations support, including: protocol development, site...

Artificial Intelligence: What you need to know about next-gen smart medical device compliance

Recent strides in artificial intelligence (AI) and machine learning technology is opening the door to the development of increasingly smart medical devices capable of turning big data and digital information into actionable insights for healthcare professionals. AI is having a significant impact on the evolution of smart devices and how healthcare will be delivered in the future. AI, coupled with machine learning, is calling into question what it means to approve a medical device capable of...