How to Clear a Software Medical Device

This whitepaper discusses the standards and requirements needed for a successful FDA submission and clearance for a software medical device, and also defines pre-market v.s. post-market activities, submission timelines, CFR, XGMP, QMS, and DHF. It provides resources for businesses that help to ensure regulatory compliance and prevent unnecessary costs and delays.

What's included in this free whitepaper:

  • Navigating Pre-Market Approval
  • Regulatory Costs and Timeliness
  • DIY Regulatory Kits
  • 3P510(k) ThirdParty Review
  • Choosing the Right Consultants

This powerful tool is offered for free by Beanstock Ventures, the developer of the toolkit and a trusted partner of Greenlight Guru.

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About Beanstock Ventures

BeanStock Ventures was founded by Shawnnah Monterrey, with the intention of making the development of breakthrough medical devices innovative, predicable, efficient and cost-effective for clients across the globe. Calling upon her own 20+ years experience working as a software development professional in the healthcare and life science space, as well as a skilled team of engineers, designers, quality assurance and other tech professionals with a shared passion for innovation. Visit their website to learn more.


About Greenlight Guru

Greenlight Guru provides the leading cloud-based solutions for MedTech companies to bring life-changing products to people faster, and with less risk.

Greenlight Guru provides purpose-built quality management, product development, and clinical data management solutions that together help teams accelerate timelines, streamline compliance, and deliver high-quality products.

With Greenlight Guru, companies across the globe are improving efficiency, speed, and quality in every aspect of their organization to get products to market faster and keep them on the market longer.

Visit our homepage to learn more.