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What is your email address?

What stage is your medical device currently at in the product development process?

What stage is your medical device currently at in the product development process?
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Have you identified the specific regulatory requirements (e.g., FDA 510(k), ISO 13485) that your product must meet? (If yes, what is your current progress with these requirements?)

Are you seeking guidance for regulatory compliance, product development, operations management, a combination, or something else?

Are you seeking guidance for regulatory compliance, product development, operations management, a combination, or something else?
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Do you currently have a quality management system (QMS) in place, or do you need assistance in establishing one?

Do you currently have a quality management system (QMS) in place, or do you need assistance in establishing one?
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What is your timeline for getting your product to market?

What is your timeline for getting your product to market?
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What are the biggest challenges you’re facing right now in getting your product to market?

What are the biggest challenges you’re facing right now in getting your product to market?
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Have you secured funding for your commercialization efforts? (If yes, what is your current budget for product development and commercialization support?)

How many internal resources or team members are working on your product development and commercialization efforts?

What specific outcomes are you hoping to achieve with external product management or commercialization consulting?

Are you open to a part-time/fractional consulting arrangement, or are you seeking full-time support?

How familiar are you with Lean Six Sigma methodologies and how they can be applied to your product development process?

Have you worked with external consultants in the past? (If yes, what was your experience?)

Are there specific milestones or regulatory approvals you’ve already achieved?

Would you prefer ongoing consulting support or a one-time intensive strategy session to address your current needs?