Why Prioritize Quality Affairs?

Quality Affairs encompasses the strategies, processes, and systems that medical device manufacturers implement to ensure their products consistently meet regulatory requirements and quality standards. It involves every stage of a device’s lifecycle, from initial design and development to manufacturing, distribution, and post-market surveillance.

Our team helps you establish and maintain robust quality management systems (QMS) that comply with ISO 13485 and global regulatory expectations, ensuring that quality is embedded into every aspect of your operations.

Our Quality Affairs Services include:

• Quality Management System (QMS) Development and Support: We assist with the design, implementation, and continuous improvement of your QMS. From documentation control to internal audits, we ensure your system supports product quality and regulatory compliance at every stage.
• Supplier Quality Management: We help qualify and audit suppliers to ensure they meet regulatory requirements and quality standards. We also support supplier risk management and ensure that your supply chain is compliant and resilient.
• CAPA (Corrective and Preventive Action) Management: Our team guides you through the process of identifying, investigating, and resolving non-conformities with effective corrective and preventive actions, ensuring continuous improvement in your processes.
• Risk Management (ISO 14971): We support the development and implementation of a risk management process to identify, assess, and mitigate risks throughout your product lifecycle. This ensures your products meet safety requirements and reduce the likelihood of product failures.
• Internal Auditing and Compliance Checks: We conduct thorough internal audits to assess the effectiveness of your quality management system and ensure compliance with both regulatory and internal standards. Our audits help identify areas of improvement and ensure that your organization remains compliant with changing regulations.
• Product Validation and Verification: We support process and design validation to ensure that your devices meet both performance and safety standards. We assist in conducting validation activities such as testing and qualification to ensure that every product is ready for market.
• Complaint Handling and Management: We ensure that your company has an efficient complaint management process in place, from initial reporting to resolution. Our team helps with root cause analysis, CAPA implementation, and ensuring compliance with regulatory reporting obligations.
• Document & Record Management: We support the creation, management, and retention of essential documentation and records required for compliance with global regulations. Our services ensure that your document control system is efficient, organized, and in line with ISO and regulatory standards.
• Change Control Management: Our change control services help you effectively manage and document changes to processes, products, or systems. We ensure that all changes are well-documented and compliant.
• Training and Development: We offer customized training programs for your team on best practices for quality management, regulatory compliance, and industry-specific standards. Our training ensures that your employees are equipped with the knowledge they need to maintain a high level of product quality and meet regulatory requirements.

With our Quality Affairs services, we ensure that your medical devices meet the highest standards of safety, performance, and regulatory compliance. Our expertise in quality management systems and continuous improvement processes will help you reduce risks, improve product quality, and stay compliant in a competitive and highly regulated industry.