The FDA is hosting a webinar on February 2 for interested stakeholders to discuss the final guidance Electromagnetic Compatibility (EMC) of Medical Devices and its applicability to in vitro diagnostic (IVD) devices.
The European Commission developed the new proposal following a December 9, 2022, meeting of the EPSCO Council, where EU Ministers of Health called on the Commission to swiftly submit a proposal to extend the transition period in the Medical Device Regulation. The proposal will now be negotiated by the European Parliament and the Council.
“Many medical device and life sciences companies are still carrying out manual validation processes, using paper-based scripts, screen shots and pdfs. However, regulatory bodies, such as the FDA, are encouraging companies to take a more automated approach using computer system assurance (CSA). We are in a strong position to support companies in achieving the huge benefits this has to offer.”
Jordi labs and its team of Ph.D. analytical chemists developed a proprietary, multi-detector approach to ensure that all extractables are accurately characterized to comply with global materials testing regulatory requirements.
Peter O’Blenis, CEO of Evidence Partners, discusses the growing role—and challenges –of literature reviews in the medtech market.
Rapid developments in healthcare technology, combined with improved data collection, pandemic pressures and increased consumer demand for tech-enabled and virtual health care, are fueling innovation and transformation in the digital health space.
As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.
As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.
The AHRQ brief proposes a framework to assess the risk/safety, technical functionality and mental health features of apps. The framework can be used by advocacy organizations, payers, healthcare systems and others to inform selection of mental health mobile apps.
New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.
Embracing compliance is a continuous process, and investing in agile technologies that streamline workflows—especially in meeting EU MDR and IVDR requirements—is essential, says Lana Feng, Ph.D., CEO-founder of Huma.AI, a pioneer in a human-centered AI.
