Grant Thornton (Chicago) today announced the launch of its SmartMDR and SmartIVDR cloud-based assessment and project management tools for medical device and diagnostics companies.
The software products are meant to help medtech organizations assess compliance, estimate costs, prioritize remediation activities and monitor real-time progress toward compliance deadlines when it comes to the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in the European Union.
Preparing for the heightened E.U. regulatory requirements has been a major priority for many medical device companies.
“A number of factors are combining to create a perfect storm,” said Marty Zuzulo, compliance risk director at Grant Thornton.
“The regulations themselves are sweeping — almost a doctrinal shift in certain areas from previous directives,” Zuzulo said. “On top of that, the regulations diminish the number of notified bodies, or third-party agents, certified to conduct compliance assessments and audits. The more stringent regulatory environment and the throttling of the review and approval ‘supply chain’ is creating significant challenges for affected companies.”
Grant Thornton officials are touting the SmartMDR and SmartIVDR tools as a structured, repeatable way for companies to conduct and capture technical and quality document assessment data. Medtech companies will be able to estimate the cost and amount of effort needed to remediate gaps identified in product compliance assessments.
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