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FDA CDRH Releases Proposed Guidances for 2023
Cybersecurity, remanufacturing of devices and chemical analysis for biocompatibility assessment of medical devices are among the topics FDA plans to address through draft and final guidances in 2023.
Cybersecurity, remanufacturing of devices and chemical analysis for biocompatibility assessment of medical devices are among the topics FDA plans to address through draft and final guidances in 2023.
Mahofski will be responsible for identifying and pursuing acquisition opportunities that complement RQM+’s core regulatory services and provide a comprehensive range of fully integrated outsourced solutions to help get MedTech products to market faster and ensure ongoing regulatory compliance.
The $16.6 billion acquisition will bring Abiomed’s breakthough Impella heart pumps into the Johnson & Johnson MedTech portfolio.
The expansion of BlackHӓgen’s HFE team and other critical usability-focused design groups, such as the UX team, will support the company’s ability to deliver its expertise to a wider range of MedTech customers.
Veeva Vault CRM for Medtech is a unified customer relationship management (CRM) and content management application built for medtech sales teams, key account managers and medical affairs professionals.
Bringing design and quality assurance processes together earlier in the device development process can reduce costs and nonconformances, while improving outcomes.
“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.”
The goal of the TAP Pilot is to reduce the time from concept to commercialization of medical devices by facilitating robust engagement early in the process with the FDA, industry and key stakeholders.
The two new final guidances are intended to increase transparency to stakeholders on the FDA’s approach to the issuance and tracking of 522 orders and post-approval study requirements.
John Taylor has 30 years of software development and senior leadership experience. Prior to joining ETQ in 2018, he was senior vice president with PTC.