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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

Mobile Medical Apps

In today’s wireless world, it seems everyone has a smartphone and it’s revolutionizing how services and information are presented and accessed. In the healthcare industry, this means rapid advances in telemedicine and the development of mobile medical apps (MMAs) which raise some unique concerns for compliance and challenges for regulation by the FDA and medical regulatory submissions. It is important to determine if your product is a regulated MMA or not a medical device. On May 17, 2019, the...
MEDIcept

Digital Health Innovation and Regulatory Compliance

Advances in digital health technology and innovation are picking up speed as wireless communications continue to evolve and become incorporated in growing numbers of devices, systems, and networks. The cloud, , are only fueling the demand for wireless and cloud-based integration of medical devices, which promises to improve the delivery of healthcare, often at reduced costs. Telemedicine, wearable devices, artificial intelligence (AI), and remote diagnostic and monitoring systems are just some...

Two Premier Medical Device Firms Merge to Provide More Comprehensive Services

Ashland, MA: MEDIcept Inc, a leading international quality and regulatory consulting firm focused on medical device and in-vitro diagnostics (IVD), and Reilly & Associates, a US-based privately held consulting firm specializing in medical device/biotechnology, announces the merger of the two companies.The merger promotes the shared strategic goal of becoming a world-wide, leading quality and regulatory value-added service firm focusing on medical devices and medical technology....