Grant Thornton LLP has launched its cloud-based assessment and project management tools, SmartMDR™ and SmartIVDR™, for use by diagnostics and medical device companies for compliance with the 2017 requirements of the European Union Medical Device Regulation and In Vitro Diagnostic Regulation. The new requirements reclassify some medical devices and increase the amount of safety and performance evidence that diagnostics and medical device companies need to demonstrate before they can be marketed in the EU.

“Grant Thornton launches SmartMDR™ and SmartIVDR™“

Compliance Risk director at Grant Thornton, Marty Zuzulo, said: “A number of factors are combining to create a perfect storm. The regulations themselves are sweeping, almost a doctrinal shift in certain areas from previous directives. 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. Our SmartMDR and SmartIVDR tools allow for rigor and consistency in what is a program management challenge within many organizations. They establish a structured, repeatable way for companies to conduct and capture technical and quality document assessment data, and to estimate costs and levels of effort to remediate gaps identified in product compliance assessments. The bottom line is that without overhauling ad-hoc approaches to product compliance assessments, companies’ revenue is at risk, and they need a robust way to protect it. These tools can help companies stay compliant and preserve revenue.”