A group of medical practitioners are conversing in a hospital corridor - Global Regulatory Strategy and Submissions | NSF

Getting Ready for Medical Device Market

Prepare for market launch by conducting clinical trials, developing regulatory filing strategies and ensuring inspection readiness through training and auditing.

Work with our team of former regulators and industry experts to audit your quality systems, conduct clinical trials, prepare for inspections and file regulatory submissions in order to bring your products to market.

How Can We Help?

Performing Audits

NSF offers a variety of mock audits to help you ensure regulatory readiness. Assess a wide range of regulatory requirements to identify areas of risk and perform due diligence activities, or rely on NSF to support your internal and supplier audit programs.

Global Regulatory Strategy and Submissions

Receive your customized regulatory strategy from our team of former regulators and technical experts to efficiently bring innovative medical devices, in vitro diagnostics and combination products to market.

Clinical Trial Support

NSF provides efficient, effective clinical trial support and product development strategy. We help you optimize time and cost throughout the process while maintaining the highest levels of quality, integrity and scientific excellence.

Inspection Readiness

Schedule a mock audit or readiness inspection to prepare your team for the regulatory audit and inspection process. Our team of former FDA and MHRA regulatory inspectors provides detailed feedback, strategic advice and inspection support. If requested, we include “hats-on, hats-off” services.

Resources

Germany Focuses on Digital Health Applications (DiGAs)

Read our article in the Journal of Medical Device Regulation on data protection and security and the positive care effects of digital health applications.

Insights and Expertise

White Paper: Tools and Tips for Writing Effective Nonconformity Statements During Quality Management System Audits of Medical Device Manufacturers

As a medical device quality management system auditor, one of the most important (if not the most important) responsibilities of your role is to effectively communicate identified nonconformities to the auditee organization.

Key FDA Policies, Procedures and Practices Before, During and After Medical Device Manufacturer Inspections

This paper by expert Rob Ruff provides a behind-the-scenes look at how FDA medical device inspections are planned, conducted and managed.

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News and Events

NSF Now Offering Live Instructor-Led Virtual Pharmaceutical and Medical Devices Training

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.

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