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About

MEDIcept is a vertically integrated medical device quality assurance, regulatory consulting and contract testing firm owned and managed by medical industry professionals with direct experience managing medical device development, operations, quality, and regulatory activities.

With decades of combined experience in medical device design and manufacturing and regulatory compliance, we are uniquely qualified to help medical device, in-vitro diagnostic, and plasma pharmaceutical companies navigate complex FDA and international regulatory pathways, reduce business risk and time-to-market while maximizing the potential for success in the market.

We provide our clients with a wide range of services, including:

  • Regulatory strategies
  • Regulatory submission
  • Quality assurance system development
  • Temporary Quality and Regulatory personnel
  • FDA and ISO 13485 compliance audits
  • Mock FDA Inspections
  • Mock FDA audits
  • ISO 14971 risk management system development
  • Third party internal and supplier audits
  • Design and regulatory due diligence
  • Product corrective and preventive action program development

MEDIcept
200 Homer Ave
Ashland, MA 01721

Phone
508-231-8842

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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...