Stop Drowning In Regulatory Guidance And Start Swimming Ahead
Sherif Elkhadem Sherif Elkhadem

Stop Drowning In Regulatory Guidance And Start Swimming Ahead

Regulatory guidance document overload is crushing MedTech startups with 190+ new FDA documents in 2023 alone. While the majority of companies rely on fragmented spreadsheets and email folders. While many teams still rely on fragmented tools, such as spreadsheets and email folders, to manage updates, forward-looking startups are building centralized regulatory intelligence systems that streamline compliance and accelerate submissions.

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One Audit, Five Markets, Unlimited Potential for Medical Device Startups
Sherif Elkhadem Sherif Elkhadem

One Audit, Five Markets, Unlimited Potential for Medical Device Startups

Expanding a medical device startup globally is challenging, but regulatory harmonization offers a faster path to market. By leveraging the Medical Device Single Audit Program (MDSAP) and Mutual Recognition Agreements (MRAs), startups can streamline approvals, reduce compliance costs, and enter multiple markets efficiently. Learn how leading medical device companies are using these strategies to scale faster.

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