Outsourcing Services

Medical device companies face increasing pressure to navigate complex regulatory frameworks while maintaining efficient operations. Our outsourcing services allow manufacturers to leverage our experience and expertise in areas like clinical trials, regulatory submissions, and quality management, helping reduce the burden on internal teams while ensuring compliance with global standards. By outsourcing key functions to our team of experts, you gain access to specialized knowledge in areas like FDA-compliant audits and international regulatory submissions.

Our outsourcing services are designed to provide flexibility and scalability, allowing you to expand or contract resources as needed. Whether you need temporary support for a specific project or long-term assistance with regulatory or quality management functions, we can provide tailored solutions that meet your needs. We work closely with your internal teams to ensure seamless integration of outsourced services, minimizing disruption and improving operational efficiency.

We support manufacturers through every stage of the product lifecycle, from early-stage development through post-market surveillance. Our team assists with clinical trial management, ensuring that studies meet the regulatory requirements of bodies like the FDA, EMA, and other global authorities. We provide end-to-end clinical trial services, including study design, site management, data collection, and regulatory reporting, helping manufacturers generate the clinical evidence needed to bring products to market.

In addition to clinical trials, we assist with regulatory submissions, helping manufacturers prepare and submit 510(k) applications, CE mark submissions, and post-market surveillance reports. We ensure that all submissions are accurate, complete, and aligned with the latest regulatory requirements, reducing the risk of delays or rejections. By outsourcing regulatory submissions, manufacturers can focus on innovation and product development while we handle the complex and time-consuming submission process.

Our outsourcing services also include support for quality management systems (QMS) and supplier audits. With increasing scrutiny on supply chain management, ensuring that your suppliers meet regulatory standards is critical to maintaining compliance. We help manufacturers conduct supplier audits and manage corrective actions, ensuring that your entire supply chain is aligned with regulatory expectations like those set by the EU MDR and ISO 13485.

By outsourcing key regulatory, clinical, and quality functions to our team, you can reduce operational costs, improve efficiency, and ensure that your products meet global regulatory standards. Whether you need full-service outsourcing or targeted support for specific functions, our expertise ensures that your company remains compliant and competitive in the global medical device market.

Our outsourcing services include:

• Audits – internal / supplier / gap: Conduct comprehensive audits to identify compliance gaps and ensure supplier and internal processes meet regulatory standards, including M&A due diligence and data integrity.
• Training (In-Person / E-Learning / Virtual): Provide public and customized training programs to ensure your team is equipped to meet regulatory and operational requirements.
• Clinical Trials & Clinical Affairs: Manage clinical trials and related activities to support regulatory submissions and ensure ongoing compliance. NSF integrates clinical trial management with technical documentation, providing a comprehensive solution that ensures regulatory compliance and operational efficiency.
• Regulatory Affairs & Compliance: Navigate complex regulatory frameworks with expert support in managing submissions, approvals, and ongoing compliance, including technical documentation & GAP analysis and post inspection response.
• Post-Market Surveillance / Pharmacovigilance / MDR / IVDR: Ensure ongoing product safety and compliance with post-market surveillance and pharmacovigilance activities, including MDR/IVDR requirements, complaint handling, risk assessments and recalls.
• Quality (QMS): Maintain a compliant and efficient quality management system to meet global regulatory requirements including, QMS auditing, creation, and complaint management and CAPA management.
• Validation Services: Ensure processes, systems, and equipment are validated according to regulatory standards for quality and compliance, including software, process, method and more.

By outsourcing key regulatory, clinical, and quality functions to our team, you can reduce operational costs, improve efficiency, and ensure that your products meet global regulatory standards. Whether you need full-service outsourcing or targeted support for specific functions, our expertise ensures that your company remains compliant and competitive in the global medical device market.

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.