Call Us Today at 508-231-8842        EMERGENCY

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 remediation, acquisition, or growth.

The merger promotes the shared strategic goal of becoming a leading, international, value-added consulting firm focusing on medical devices and medical technology. This merger offers the opportunity for MEDIcept to more effectively serve their customers, ranging from start-up, virtual medical device manufacturers to Fortune Global 500 firms.

Both MEDIcept and QSIM share a common goal to positively impact medical device compliance and safety. This acquisition provides us with an opportunity to provide medical device manufacturers with value added services as they introduce devices into new markets.

According to F. David Rothkopf, President of MEDIcept, “As part of our strategic plan, MEDIcept is expanding our core competence and expertise in Quality Systems. This merger will provide our clients with greater resource offerings through the QSIM’s deep experience with remediation.”

“This merger will provide QSIM clients with access to a broader group of seasoned industry experts,” said Brian Markham, President of Quality Systems in Motion.  In addition to QSIM’s quality system consulting, MEDIcept will provide our client base with expertise in the areas of clinical studies and regulatory submissions.”


About MEDIcept:

MEDIcept was established in 1996 to offer innovative, trusted, and cost-effective Quality, Regulatory, and Clinical solutions to the medical device and invitro diagnostic industries. With decades of experience, we are uniquely qualified to help clients navigate complex FDA and international regulatory pathways, reduce business risk and time-to-market, while maximizing the potential for success in the market.

About Quality Systems in Motion (QSIM)

QSIM was founded in 2011 to provide expert consultation resources to medical device, biotech, and pharmaceutical organizations facing challenging compliance concerns.

Sign up to receive our Newsletters!

The Latest News

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...

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...