Why download?
Our handbook walks you through the medical device launch journey step by step, breaking down the entire process into three clear, actionable phases: Business Plan, Device Development, and Device Launch.
Inside, you’ll discover:
- Business plan: Learn how to assess the market, budget accurately, and plan your prototype and regulatory strategy to set your medical device project up for success from day one.
- Device development: Understand how to manage design controls, mitigate risks, build a compliant QMS, and prepare the technical and clinical documentation needed for regulatory approval.
- Device Launch: Get guidance on global product registration, post-market surveillance, and maintaining your technical file to ensure long-term compliance and market success
This is a must-download for anyone involved in, or looking to enter, the medical device market, packed with top tips to guide your journey.
