Emerging Regulations and Technical Support Services

The global regulatory landscape is continuously evolving, with new guidelines and requirements emerging to address the challenges posed by innovative technologies such as Software as a Medical Device (SaMD), artificial intelligence (AI), and machine learning (ML). As medical devices become more complex, manufacturers must stay ahead of these changes to ensure compliance with new and existing regulations. Our emerging regulations and technical support services provide the expertise needed to navigate these evolving frameworks and maintain compliance in an ever-changing environment.

The FDA, the European Medicines Agency (EMA), and other regulatory authorities are developing specific guidelines for the approval and use of digital health technologies such as SaMD. These devices, which often utilize AI and machine learning to enhance their functionality, face unique regulatory challenges. Our team helps manufacturers understand and comply with these regulations, from the initial development phase through to market access.

In addition to these emerging technologies, regulations for combination products are also evolving. The FDA has specific guidelines for combination products, which involve a combination of drugs, devices, and/or biologics. Navigating the regulatory pathways for these products can be challenging due to the complexities involved in integrating different product types. We provide comprehensive support, ensuring that combination products meet the required regulatory standards across multiple jurisdictions.

Changes to established regulations such as the EU MDR also pose challenges for manufacturers. We help companies stay compliant with these updates by providing regulatory gap assessments, updating technical documentation, and advising on compliance strategies. Our experts ensure that your products remain compliant with the latest requirements, helping you avoid costly delays and compliance issues.

Our services include:

• LDT Regulation – GAP Assessment and Remediation: Identify and address gaps in Laboratory Developed Tests (LDT) compliance.
  • Quality Systems
  • Gap assessment of laboratory's current system versus 21 CFR Part 820
  • IVD Classifications (FDA)
  • Confirm classification for each individual test, assay, instrument, software
  • Regulatory Pathways for LDTs
  • Help determine how to list your tests (i.e., 510(k), De Novo, PMA)
  • Quality Management System Development
  • Help with establishing required processes, procedures
  • Provide training to employees on the requirements of 21 CFR Part 820
• Staffing / Extended Bench: Provide regulatory and technical experts to support your ongoing projects and needs.
• Intelligence and Machine Learning (AI/ML): Ensure AI/ML compliance in medical devices and optimize product performance.
• EU MDR/IVDR Implementation: Navigate the latest EU regulations for medical devices and IVDs to meet compliance standards.
• FDA QMSR - ISO 13485 Transition: Smoothly transition to FDA’s adoption of ISO 13485, aligning with global quality standards.
• M&A Due Diligence and Integration Support: Conduct regulatory due diligence and ensure seamless integration during mergers and acquisitions.
• FDA’s Case for Quality: Align your processes with the FDA’s Case for Quality initiative to improve product quality and compliance.
• Expert Witness Services: Provide expert regulatory testimony for legal matters involving medical devices.
• Combination Products: Navigate the regulatory complexities of combination products for proper classification and approval.
• Sustainability – Design, Manufacture, Distribute, Reuse/Recycle: Implement sustainable practices across your product lifecycle to meet regulatory and environmental goals.
• SaMD / SiMD / SaaS Support: Ensure compliance with evolving regulations for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) and Software as a Service.

In addition to regulatory support, we offer technical assistance with areas such as risk management, product development, and process optimization. We help manufacturers design and implement strategies to meet regulatory standards while streamlining their operations. Whether you’re preparing for a submission under new regulations or updating existing products to meet evolving standards, our technical support services ensure you’re ready for what’s next in the global regulatory landscape.

By staying informed about regulatory trends and future shifts, we help manufacturers mitigate risks, maintain compliance, and bring innovative products to market efficiently. Our global expertise allows us to support companies operating in diverse regulatory environments, ensuring compliance regardless of market or region. Whether you’re introducing cutting-edge technologies or preparing for the impact of new regulations, we provide the guidance and expertise needed to thrive in an ever-evolving industry.

At NSF, we take a different approach. We focus on helping you build sustainable, lasting improvements at every stage of the product lifecycle, from regulatory compliance and quality systems to product development and beyond. With a team of seasoned regulators and industry professionals, we don’t just hand over solutions – we work alongside you to implement practical tools and strategies that keep your systems running smoothly.

By empowering your team and strengthening your processes, we ensure that what we build together will continue to thrive long after we’re gone. It’s a true partnership, where your success is our success.