Archive: Medical Device Regulatory Guidance

Budget 250$ per month

Posted: 5 years ago

Closed

Description: US based Start-up company with a Class 1 FDA medical device with multiple predicates seeking help with preparing its Pre-Submission package to FDA. Looking for an expert who has helped other small companies with their FDA registration. Device is an orthopedic brace / orthosis for the lower limb, non-intrusive.
Our device fits into the FDA category: 890.3475 Limb orthosis.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=890.3475

Need to understand when we should file our pre-sub, when we should register, how long each of these steps take, the cost associated with the steps, and the amount of effort associated with preparing packages for each step.

Also needing to get advice on impact of patient preference data, and how to document patient preferences so that it can be used in submissions.

Would like to get a quote for a single coaching call to talk us through these steps, and then after that call - to get a quote for helping to file these packages with us.
Working conditions:
Fixed Price
Under $250
Skills:
medical devices,fda,regulatory