Regulatory Services

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.

Regulatory Strategy Reports

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.

Gap Assessments

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

Preclinical Testing Support

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

Due Diligence Assessments

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

Regulatory Agency Meeting Support

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.

Premarket Submission Support

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)

WHO Prequalifications for IVDs

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.

EU MDR Preparation and Compliance

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.

EU IVDR Preparation and Compliance

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.

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