Most medical device companies do not have staff who are prepared to handle a recall or an FDA 483 warning letter. Hopefully, they will never need to. The person who manages this type of project will need more than just technical and regulatory capability. They need to have the thoroughness and patience to work through each issue that the FDA raises or the medical device project requirements to prove that the product can go back on the market safely.
Waddell Group has several project managers who possess this thoroughness and can help calm the team that receives the FDA 483 warning letter or is told to recall their product. We offer FDA meeting guidance to ensure things are accomplished correctly while bringing a sense of urgency to meet FDA accelerated approval deadlines.