Medical Device Recall Management

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.
Step 1: Identify the Key Challenges Facing the Company

We do this by differentiating facts from fabrication and understanding the tangible from the intangible. A thorough GAP analysis helps understand the level of the crisis faced by the company and its impact and significance on the company’s ongoing projects, vision, and mission. This includes identifying the resources available to manage the crisis.

Step 2: Create a Comprehensive Project Management and Recall Plan

Our roadmap accounts for all the departments and personnel affected by the recall. This includes ensuring the company and the applicable regulatory body work together to resolve the issue using open communication and a feedback loop when appropriate.

Step 3: Execute the Plan With Urgency and Accuracy

Our expert consultant leads the recall management team with trust and confidence after pulling in all personnel and groups central to executing the plan. We ensure everyone has everything they need to get the product back on the market. This includes factoring in the impacts that ongoing projects have on the capacity of the key personnel involved in the recall.

Step 4: Reflect on the Factors and Actions That Led to the Crisis

Then, identify which systems and processes need to be implemented or changed to safeguard the company in the future.

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.

Find out how we reintroduced a company’s flagship product back in the market after a recall.

With our team of experts at the helm of your recall management, you can be confident that your product recall is handled with the urgency and accuracy it deserves.