Medical Device Recall Management
Most medical device companies are ill-prepared to handle an FDA 483 warning letter, much less a product recall. Product recalls can lead to significant financial and reputational losses in addition to low staff morale and a massive drop in market share. It’s prudent to have an expert well-versed in the best practices of recall management by your side from the beginning to mitigate these risks or avoid them altogether.
Waddell Group’s experienced consultants and project management experts have worked with medical device companies across the globe to get them moving in the right direction during crises like product recalls.
Our Proven 4 Step Framework Will Safely Bring Your Product Back to Market
We customize our recall management framework to your company’s unique problems and challenges.
From receiving and acting on an FDA 483 warning letter to handling warnings, compliance, consent, and recall, our team of expert consultants and project managers are well equipped to handle every aspect of medical device recall management. Including successfully reintroducing a company’s recalled flagship product back in the market.
Our project managers and consultants:
- Have the technical and regulatory capabilities to properly address every issue that the Regulatory Body raises.
- Know how to lead teams, manage calmly in times of crisis, and influence change.
- Have the patience and thoroughness to find the correct solution for any unique case.
- Have at least ten years of experience in the medical device industry across various specialties.