『Beyond MDSAP: Pure Global's Playbook for Smarter, Faster MedTech Global Market Access』のカバーアート

Beyond MDSAP: Pure Global's Playbook for Smarter, Faster MedTech Global Market Access

Beyond MDSAP: Pure Global's Playbook for Smarter, Faster MedTech Global Market Access

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 This episode of MedTech Global Insights challenges the one-size-fits-all approach to global regulatory compliance. We dive into the Medical Device Single Audit Program (MDSAP), exploring its benefits but also questioning whether it is the default best choice for every MedTech and IVD manufacturer seeking international growth. We uncover the powerful alternatives to MDSAP, focusing on a strategic, modular approach that can save you critical time and resources. Learn how to leverage your existing certifications and technical documentation to create efficient, targeted pathways into key markets, ensuring a faster return on investment and a more agile global expansion strategy. Case Study: Imagine you're a European MedTech firm with a CE mark, eyeing the lucrative Brazilian market. The conventional path might suggest a costly and lengthy MDSAP audit. But what if that process delays your entry by a year and drains resources you need for marketing. This episode explores a direct, faster route to ANVISA approval, bypassing the parts of MDSAP you don't need. In This Episode, We Ask: 1. Is the high cost and extensive scope of MDSAP always justified for your company's goals? 2. How can you leverage your existing ISO 13485 certificate and CE marking for approvals outside the EU? 3. What are the critical differences between a full MDSAP audit and a country-specific inspection, like for Brazil's ANVISA? 4. For a startup with limited resources, what is the most efficient pathway to enter your first two or three international markets? 5. How can a modular regulatory strategy help you scale into regions like Latin America or Southeast Asia without committing to MDSAP? 6. When does choosing MDSAP become a strategic advantage versus a regulatory burden? 7. How can technology and local representation de-risk and accelerate individual country submissions? Contact us for more information at info@pureglobal.com or visit https://pureglobal.com/.
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