FDA recently issued a Letter to Industry regarding medical device submissions that contain fraudulent and unreliable third-party testing data.  In this letter, FDA reminds industry that they must carefully evaluate third parties with whom they engage to conduct performance testing.  Ultimately, it is the responsibility of the sponsor or device manufacturer to qualify third parties that generate data and ensure that all information submitted to FDA is truthful and accurate. Many sponsors likely do not realize that they have outsourced their project to an unaccredited or unreliable tes ..read more

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The European Medical Device Regulation (MDR) is a new set of regulations that will become effective May 2020. This new set of regulations will replace existing directives of the EU regulatory framework, Medical Devices Directive (MDD) and Active Implantable Medical Devices (AIMD) Directive, to keep up with scientific advances in the medical industry, improve consistency, and increase patient safety. Compliance with the new regulation is mandatory for medical device companies who produce and distribute medical devices in Europe. Once the EU-MDR is in effect, MRI labeling will be required for al ..read more

To maintain compliance with heightened requirements under the Medical Device Directive (i.e., recent Notified Body implementation of MEDDEV 2.7/1 rev 4) and the new European Medical Device Regulation (MDR), manufacturers of certain classes of devices are required to update and evaluate periodically all of the available information about the performance of a device, throughout its lifetime on the market.   The level of evidence necessary to satisfy these requirements is increasing, as is the frequency with which these evaluations will be required for each device.  Compliant Clini ..read more

West Lafayette, IN: MED Institute obtained FDA qualification of their MDDT (Medical Device Development Tool) for virtual MRI safety evaluations, to determine if MRI imaging is safe for patients with implanted medical devices. The MDDT program supports innovation in medical device development and regulatory science, helping to bridge the gap between research of medical devices and delivery of devices to patients. The program provides FDA with qualified tools that medical device sponsors can utilize during the evaluation and development of medical devices. To earn qualification, FDA evaluates th ..read more

An external fixation device refers to a device that provides stability and alignment for fractured bones and can be adjusted externally. The device is partially implanted in tissue and bone but a portion of the device remains external. These devices may consist of external elements (bars, rods), connector elements (clamps), and anchorage elements (pins, screws, wires). These devices are commonly used to heal bone fractures in the forearms, legs, hands, and feet following traumatic injury. https://medical-dictionary.thefreedictionary.com/external+fixator External fixation devices behave diffe ..read more

Although the implementation of EU MDR has been postponed for up to one year, it will be important to continue working towards compliance with the new regulations.  The European Medical Device Regulation (MDR) is a new set of regulations that will now become effective May 2021. This new set of regulations will replace existing directives of the EU regulatory framework, Medical Devices Directive (MDD) and Active Implantable Medical Devices (AIMD) Directive, to keep up with scientific advances in the medical industry, improve consistency, and increase patient safety. Compliance with the new ..read more

There are several safety concerns for patients with metallic implants who require MRI, including magnetic forces, torques, radiofrequency-induced heating, gradient induced heating and vibrations, unintended stimulation, and device malfunction.  We help medical device manufacturers evaluate their devices for safety in the MRI environment and perform physical testing according to ASTM F2052, F2213, F2119 and F2182 [1-4].  After the physical testing is complete, we provide the necessary information for MRI safety labeling and supporting scientific rationale that is reported in the instr ..read more

We have recently expanded our capabilities to include MRI safety evaluation of electrically active devices to our scope of accreditation. MED Institute is accredited to ISO/IEC 17025:2017, BSI certified to ISO 13485:2016, and BSI audited to ISO 14155:2011 by Perry Johnson Laboratory Accreditation (PJLA). Our multi-disciplinary team has most recently added ISO/TS 10974:2018 to our scope of PJLA accredited test methods. ISO/TS 10974 is a test specification used for assessing the safety of magnetic resonance imaging for patients with an active implantable medical device (AIMD). An “active medical ..read more

Our multi-disciplinary team has extensive experience in medical device simulation and testing, including but not limited to MRI safety evaluations of medical devices. Since 2014, we have been involved in a Research Collaboration Agreement (RCA) with the FDA on the topic of radiofrequency safety assessments of passive implants using computational modeling and simulation (CM&S) of devices in phantoms and virtual human anatomies. Last August the FDA published this draft guidance to promote consistency of reviews, testing, and MRI safety labeling across medical devices. In response to the draf ..read more