Hardware Podcasts

#391: Creating a Regulatory Roadmap for MedTech Market Success with Adnan Ashfaq

Global Medical Device Podcast · 14 Nov 2024 · 35m · Episode 391

What this episode covers

Adnan Ashfaq, founder of SimplyMedica, explains how to create a regulatory roadmap to guide medical device companies through market access and secure investor confidence. He distinguishes the roadmap from a regulatory strategy, detailing its role in outlining costs, timelines, and regional requirements for markets like the US, EU, and Japan. Ashfaq emphasizes that precise language in intended use statements and accurate device classification are critical to avoiding costly missteps and leveraging strategic opportunities, such as entering the UK market before regulatory tightening.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, SimplyMedica
Also
EU MDR, FDA, ISO 13485, MDSAP

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