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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

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...