Quality Management Services

A robust Quality Management System (QMS) is vital for ensuring that medical devices consistently meet regulatory standards and maintain safe and effective performance throughout their lifecycle. Global regulatory frameworks like the FDA’s Quality System Regulation (QSR) and international standards like ISO 13485 outline strict requirements that manufacturers must comply with to ensure that quality is upheld from development to post-market surveillance.

Our quality management services are designed to help companies develop, implement, and maintain comprehensive QMS frameworks that meet these global standards. We work with manufacturers to build quality systems that address critical areas such as risk management, corrective and preventive actions (CAPA), supplier management, and internal audits. By ensuring that all aspects of the QMS are aligned with global regulatory expectations, manufacturers can reduce their risk of non-compliance and improve operational efficiency.

One of the key areas we assist with is conducting gap assessments to identify deficiencies within an organization’s QMS. Our team of experts performs thorough audits to pinpoint areas where improvements are needed to meet regulatory expectations. For instance, we help companies meet the rigorous requirements set by the EU MDR and ISO 13485 through comprehensive gap analysis and remediation plans. Whether it’s preparing for an FDA inspection or aligning with the MDR, we ensure your QMS is in top shape.

In addition to internal QMS management, we also assist with supplier quality audits to ensure that your partners are compliant with regulatory standards. This ensures that your supply chain remains reliable, minimizing risk and improving the overall quality of your product. With the rise of the Medical Device Single Audit Program (MDSAP), manufacturers now can streamline their compliance across multiple regulatory jurisdictions through a single audit. Our team helps you prepare for these audits, ensuring that your QMS is fully compliant with the program’s stringent requirements.

At the heart of our quality management services is the goal of continuous improvement. We do not just focus on helping you pass audits; we collaborate with you to create a sustainable quality culture within your organization. By integrating best practices and fostering ongoing improvements within your QMS, we help you stay compliant while improving product quality and operational efficiency. Whether you are pursuing ISO certification or undergoing an FDA inspection, our expert team provides the support you need to build and maintain a” fit for purpose” QMS.

Our Quality Management Services include:

• Development, implementation, and maintenance of QMS according to global standards (21 CFR Part 820, ISO 13485, ISO 9001)
• Audits and gap assessments of existing QMS to identify specific areas of non-compliance and opportunities for improvement
• Remediation of findings from regulatory inspections or audits
• QMS Development and Improvement
• QMS Tools and Processes
• Quality management system training, available both face-to-face and virtually
• CAPA (Corrective and Preventive Actions) management to address and resolve compliance issues
• QIP / Remediation
• Mock recalls
• Clinical support throughout the lifecycle of the device to ensure compliance with regulatory standards
• Validation services, including Computer System Validation (CSV) according to ISO/TR 80002-2
• Implementation of unique device identification (UDI) systems
• Supply chain integrity and post-market quality management support
• Evaluation and certification of QMS against regulatory and normative requirements (e.g., ISO 13485, 21 CFR 820, EU MDR, EU IVDR)
• Process management implementation for optimizing and further developing QMS processes
• QMS Maturity (QMM) Assessments to ensure your quality management system is aligned with industry best practices and regulatory requirements
• Complaint Management to proactively manage and resolve complaints, ensuring compliance and customer satisfaction
• Global expertise in regional requirements, including U.S. FDA regulations, Australian TG(MD)R, Brazilian Good Manufacturing Practices, Japanese MHLW, and more.

At the heart of our quality management services is the goal of continuous improvement. We don’t just focus on helping you pass audits; we work with you to create a sustainable quality culture within your organization. By integrating best practices and fostering ongoing improvements within your QMS, we help you stay compliant while improving product quality and operational efficiency. Whether you are pursuing ISO certification or undergoing an FDA inspection, our expert team provides the support you need to build and maintain a” fit for purpose” QMS.

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.

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

Medical Device Complaint Handling and Servicing
This course examines the importance of a properly functioning complaint handling system and the relationship between complaints, service reports, U.S. medical device reporting and corrective and preventive actions (CAPA). It provides a side-by-side comparison of complaint handling requirements in the U.S. versus those in the ISO 13485:2016 standard.

Ensuring Quality: The Responsibility of Top Management in Medical Device Manufacturing
A quality management system is dynamic and complex. Top management must be prepared for ever-evolving customer, regulatory, and internal expectations; and understand the interactions of the various quality management system processes.