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Remediation

Receive expert guidance in product development, market application, manufacturing, distribution and continuous monitoring of your medical devices, IVDs and combination products.
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NSF designs and implements robust solutions related to the complex development, approval, marketing and manufacturing of FDA-regulated products throughout the total product lifecycle.

Three key indicators are at the heart of our most successful, positive and sustainable remediation projects:

Company Culture

Your company's culture, organization and support systems directly impact how teams execute remediation activities. Remediation projects succeed when a company aligns its organization with a common vision to meet regulatory requirements and support business strategy.

NSF offers planning and strategic services that help companies align business goals with regulatory requirements. From corrective action planning to quality system remediation, NSF supports your team's remediation efforts.

Communication

Clear and consistent communication ensures that members of your organization have a common understanding of why sustainable organizational improvements are required. It includes detailed plans and strategies for remediation project activities, as well as expectations for directly affected personnel and support staff. Communications must be planned, measured, consistent and managed to ensure organization-wide support for your efforts.

In addition to planning and strategy support, NSF provides the following communication services:

  • Medical devices FDA Form 483 correspondence
  • Warning letter responses
  • Regulatory agency major nonconformity responses
  • Field safety notices (FSNs)
  • Field safety corrective actions (FSCAs)
  • Recall letters and correspondence
  • Patient and user communications

Collaboration

Establishing a quality system that meets your regulatory and business needs is challenging enough. In most instances, it requires the input of third-party experts. Strengthening relationships between team members and your overall organization spurs organizational change. As team members collaborate toward a common goal, they share openly, discuss solutions and build consensus.

To support your company as you collaboratively identify and address gaps, NSF conducts baseline assessments, due diligence assessments, third-party internal audits, FDA mock regulatory readiness inspections and QSIT audits.

Your success is our success. When you use the right expertise to develop the right solutions, your organization stays on the road to sustainable quality.

Ready to Begin the Process?

Contact us with questions or to receive a quote.

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