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Validation

Medical device testing is a rigorous and complex process that demands careful planning and attention to detail. Our state-of-the-art testing facility is equipped with a wide range of systems and tools enabling us to provide comprehensive testing services, including test feasibility, design and implementation, protocol development, and complete results interpretation and reporting.

MEDIcept can help develop and execute qualification testing and process validation protocols and reports. We can prepare and implement protocols for packaging and aging qualifications, sterilization validations, and biocompatibility testing final reports suitable for regulatory submissions. We can also apply these same skills to testing conducted at your facility on your processing equipment.

 

Specific testing services include:

  • Design verification and validation
  • Usability testing
  • Package/Ship testing
  • Process/equipment qualification
  • Software validation
  • Integration validation
  • IQ/OQ/PQ process validations
  • Product biocompatibility studies
  • Product & accelerated age testing
  • Sterilization validation

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The Latest News

FDA Updates Special 510(k) Guidance

FDA’s Special 510(k) submission process has been around for years as an expedited method to demonstrate that the device to be marketed is at least as safe and effective (i.e., substantially equivalent), to a legally-marketed device not subject to the Premarket Approval (PMA) process. In September 2019, a modified version of this program was published to create a streamlined review of technological changes made to a manufacturer’s own cleared device which leveraged design control requirements....

Metal Implants: FDA’s November, 2019 Immunology Devices Panel Meeting

The Immunology Devices Panel of the FDA’s Medical Device Advisory Committee met in November to discuss the topic of immunological responses to metal-containing products regulated as medical devices. The panel focused on metal-containing implants as well as dental amalgam. Recent post-market issues with some metal-on-metal orthopedic implants and gynecological metal-containing implants have raised questions about the potential for some patients to develop unexpected or heightened biological...

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...