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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

FDA Inspection? We Can Help You Relax.

Nothing can strike fear into the heart of a medical device manufacturer quite like an unexpected notice from the FDA. How you prepare for an FDA inspection? What is the process? What are they going to look for? Are they really that mean? After the inspection how do you respond to a 483 notice or worse what happens if you received a warning letter? How you perform during the inspection can make all the difference in the world between a quick resolution and a long expensive remediation program....
MEDIcept

Validating Medical Devices

One of the cornerstones of medical device manufacturing is the ability to efficiently and cost-effectively validate medical devices to ensure FDA compliance and to successfully and profitably bring medical products to market. Proper validation is a core requirement for any medical device manufacturer looking to achieve regulatory agency compliance and sell their products domestically and internationally. At MEDIcept, we understand that medical device testing is a rigorous and complex process...

We are state-of-the-art in the validation process

US Food and Drug Administration (FDA) and international regulatory standards continue to evolve and become more stringent as medical devices become more complex in design, functionality, and technological integration. This makes the process of medical device validation and verification even more important—not only to comply with regulations, but also to aid in the design of the highest-quality components and the production process. The desired result is better repeatability, fewer mistakes,...