New Medical Device Regulatory and Standards compliance support

Posted by Bob Duffy on August 1, 2018 in Regulatory & Standards Compliance Projects

510(k), Regulatory, Standards

Challenge

Client needed technical, Regulatory and Standards compliance support to define a new product to expand their existing product lines.

Actions

• Researched alternate potential predicates for 510(k).
• Researched applicable Standards for different product features and functions.
• Evaluated technologies and technical challenge for different potential product concepts.

Results

Client was able to define the new product balancing technical, Regulatory, Standards and Marketing factors.