Navigating the CDMO Change in Medical Device Manufacturing: What You Need to Know

🚨 Med Device Leaders, questioning your CDMO change might be more than finding a new one?  

✓ How will design transfer impact your product's regulatory status across current and planned global markets?

✓ What changes to design or manufacturing processes might be necessary, and how will they affect your timelines and budget?

✓ Have you mapped out region-specific regulatory requirements and approval timeframes?

✓ Is your technical documentation package complete and transfer-ready?

✓ What specialized equipment will you need, and what are your procurement options?

✓ Would the current CDMO support the knowledge transfer?

✓ Should the new CDMO adopt your current suppliers?

✓Do you have raw materials, WIP, and finished goods in the inventory to transfer?

✓ How will you maintain inventory levels during the transition period?

✓ How do you ensure this move will not negatively impact the COGS?

✓ How to select a new CDMO? 

What are some of the questions you have asked? 

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