Regulatory Services

Navigating the complex and evolving global regulatory landscape can be challenging for medical device companies. Our team of former regulators and industry professionals is here to guide you through every step—from market entry and regulatory submissions to product modifications and post-market compliance. With in-depth knowledge of FDA, EU MDR/IVDR, and other international requirements, we provide practical solutions that help you achieve and maintain compliance across global markets.

Whether you need support with pre-market approvals, regulatory filings, or ongoing compliance, we offer a full range of services to ensure your products meet regulatory standards and reach the market successfully.

We deliver strategic assessments tailored to your business needs for medical device, in vitro diagnostic, and combination product market authorization. Our evaluations cover product classification, submission type, data requirements, and timelines to help you develop a clear regulatory path.

Whether it’s preparing through a mock FDA inspection or identifying compliance or QMS gaps via a thorough audit, our expert team is equipped to guide you. Our mock FDA inspections simulate an FDA inspection, including pre-inspection activities and can include “hats-on, hats-off” services. During the actual inspection, we can support you from the back room with our team of former FDA inspectors, former process managers, and MHRA regulatory inspectors. This initial phase sets the foundation for a robust compliance strategy.

We offer regulatory input during execution of design control activities and provide guidance for device safety and performance testing plans, protocols, and reports to ensure they meet regulatory standards.

Our experts help evaluate regulatory documentation and compliance status ahead of significant company acquisitions, allowing you to make informed decisions during mergers and acquisitions.

Our team prepares you for successful regulatory meetings by assisting with briefing documents, meeting requests, and preparatory sessions. We also support meetings with FDA and other regulatory bodies, offering strategic and tactical input for panel meetings, Q-submissions, and pre-submissions.

Throughout the pre-market submission process, we provide comprehensive services, including documentation review, submission writing, and scientific literature review. We also support FDA communications and develop response strategies for regulatory feedback to ensure your submissions are successful.

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 510K, PMA, DeNovo classification, and CE Mark Advisory
• Request for Designation (RFD) and Pre-RFD
• Device master file (DMF)
• Regulatory Pathways, Global Strategies and Timing
• Registration and Listing
• Managing Device Modifications & Changes
• Gap identification, assessments, and remediation support - US, EU, MDSAP & more
• Audit “Playbook” Development
• GMP, GLP, GCP support
• Instructor-led Training, eLearning, and Competency Assessment
• Regulatory Submissions - US, EU, Other
• FDA Pre-submission Meetings & Panel Meeting Support
• Notified bodies, agencies, and competent authorities’ correspondence support
• Audit Strategies, Back-room, and Front-room (Live Inspection) Support
• Responding to Nonconformances
• FDA Enforcement Support (483 response, warning letters, consent decrees)

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.

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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.

Regulatory compliance does not stop once you have gained market access. Global regulatory requirements evolve continuously, and keeping pace is critical. Frameworks such as the EU MDR and FDA regulations are constantly updated. We help manufacturers maintain compliance post-approval by providing ongoing support for managing product modifications and updates. Whether it is a minor tweak to a device or a substantial modification, our team ensures the changes align with the current regulatory environment.

Long-term planning is just as important as initial compliance. Our regulatory services include future-proofing your regulatory strategies by helping you stay ahead of upcoming regulatory shifts. By anticipating changes in global frameworks and evolving regulations, such as the Medical Device Single Audit Program (MDSAP), we provide manufacturers with solutions that keep them compliant across multiple jurisdictions. Programs like the MDSAP allow manufacturers to streamline compliance across multiple markets through a single audit process. We guide you through this process to reduce complexity and maintain compliance.

Our expertise spans multiple regions, and our strategic insight allows us to address the nuances of regulatory systems in the U.S., the EU, and beyond. Whether you are preparing to enter new markets or ensuring long-term compliance for existing products, we provide the guidance and services necessary for successful regulatory navigation.

We have compiled a list of articles and training courses on the issue of regulatory services to help you and your colleagues.

Medical Device Regulatory Requirements: Five-Course MDSAP Bundle
Learn what it takes to bring a product to market in each MDSAP-participating country and keep it there. We introduce the Medical Device Single Audit Program (MDSAP) and cover pre- and post-market requirements and explain how each country utilizes MDSAP in its regulatory framework.

Regulatory Strategy: A Comprehensive Guide to Navigating the Global Market
In the ever-evolving landscape of the medical device industry, having a solid regulatory strategy is crucial for success. It goes beyond simply choosing a pathway to market; it involves carefully selecting the best markets and pathways for both your device and your business.

United States Medical Device Regulations – A Comprehensive Overview
This two-hour course provides a comprehensive overview of the regulatory requirements including the regulatory framework, pre- and post-market requirements, and the way the U.S. is utilizing MDSAP.