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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

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....

How Can You Outsource Quality Assurance?

If you’re a medical device manufacturer – and especially a smaller one, such as a recent start-up – the real question might be “How can you NOT outsource quality assurance?” Smaller firms such as start-ups are especially vulnerable to issues surrounding quality assurance and quality system development. Hiring an experienced QA professional or quality engineer can cut deeply into limited funds, never mind actually getting a Quality Management System (QMS) up and running. For small or...
What You Need to Know About GDPR

What You Need to Know About GDPR

If you’re a medical device manufacturer planning do to business with the European Union you need to know about the regulatory change that took place in May 2018 that could have operational process and financial implications for your business. The new General Data Protection Regulation (GDPR) contains both existing and new data privacy requirements that, if not met, can result in significant fines of up to 20 million Euro or four percent of annual turnover. Maintaining compliance is required of...