March 2023 Medical Device and IVD News Update
March 1, 2023
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:
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.
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:
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.
Contact us with questions or to receive a quote.
March 1, 2023
February 15, 2023
January 23, 2023
May 19, 2020
To complement its face-to-face offering, NSF now offers traditional classroom courses as virtual instructor-led training to support your professional development. Courses are delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. NSF’s coaches are on hand to guide participants through the interactive sessions which also include pre- and post-course activities.