Attention those struggling with CRA and machinery regulations for medical devices!
Compliance with CRA and machinery regulations to prevent a halt in European exports. Start-up in 4 to 6 weeks.
In the medical device industry, appropriate responses to the CRA and Machinery Directive are required for the continuous export to the European market. The requirements will be applied in stages, and from September 11, 2026, obligations for vulnerability reporting and reporting of exploited vulnerabilities and serious incidents will come into effect. As the start of application approaches, many companies face challenges such as "not knowing where to start" and "lack of internal resources." This document introduces the support content of the "CRA and Machinery Directive Emergency Diagnosis Package," which diagnoses the current situation and clarifies priorities within 4 to 6 weeks. 【Usage Scenarios】 - Exporting medical devices to Europe - Responding to the CRA and Machinery Directive - Streamlining the certification acquisition process 【Benefits of Implementation】 - Continuation of exports to Europe - Increased reliability through regulatory compliance - Risk reduction through prompt responses
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basic information
【Features】 - Diagnosis of the current situation and clarification of priorities within 4 to 6 weeks - Provision of CRA and machine regulation emergency diagnosis package - Support for compliance with vulnerability reporting obligations and major incident reporting obligations - Implementation of individual consultations regarding regulatory compliance - Proposal of specific action plans tailored to your company's situation
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Company information
Vtech is a unique technology company specialized in the "verification" of LSI. Utilizing the technology accumulated from a wide variety of LSI verification projects, we also engage in research, development, and sales of our own products. Furthermore, we provide excellent products and services related to verification from around the world to our customers as an agent. We will continue to focus on verification, pursue it, and aim for our customers worldwide to incorporate "high quality" into their products.
