Global Regulatory Strategy and Submissions

Our strategic assessments of regulatory requirements address business needs for medical device, in vitro diagnostic and combination product market authorization. We offer evaluations of product classification, submission type, data requirements and timelines.

We provide submission-readiness evaluations and remediation recommendations, including reviews of device labeling.

Receive regulatory input during design control, as well as regulatory guidance for device safety and performance testing plans, protocols and reports.

Evaluate regulatory documentation and status ahead of your company's major acquisitions with the help of our experts.

We support your company's regulatory agency meetings by preparing briefing documents and meeting requests, conducting preparatory sessions and facilitating meetings with the FDA and other regulatory bodies. We provide strategic and tactical support for medical device panel meetings, in addition to Q-submission and pre-submissions.

NSF offers a range of services throughout the pre-market submission development process. This includes documentation review, submission writing or other document preparation and scientific literature review, as well as FDA and regulatory response strategy and communications.

Our services also include:

• Breakthrough devices program support for developing and requesting expedited review pathways
• Device classification via the 513(g) pathway
• Investigational device exemption (IDE)
• Premarket approval (PMA)
• Humanitarian use device (HUD)
• Humanitarian device exemption (HDE)
• Premarket notification (510(k))
• De novo classification requests
• Request for Designation (RFD) and Pre-RFD
• Device master file (DMF)

NSF has expertise in the WHO prequalification process for including products in UN procurement tenders. We assist manufacturers in navigating all assessment stages for prequalification.

Navigate significant EU MDR changes with the help of our experts. Schedule training for your staff, receive regulatory and clinical support or request an audit to prepare for everything from device classification to new requirements for technical documentation and clinical evidence.

Receive an introduction to regulatory requirements for bringing an IVD to market in the EU. Our experts offer training and support to meet the new requirements for clinical evidence, post-market surveillance and economic operators, such as manufacturers, distributors and importers.