A comprehensive range of services designed to assist you in navigating the complex regulatory landscape and ensuring compliance with quality standards. Support activities include:
Product Development Support: Guidance throughout the product development lifecycle, helping you incorporate regulatory and quality requirements into your design and development processes. Thorough reviews of technical documentation, risk assessments, and compliance with applicable standards and regulations.
Regulatory Submissions: Support in preparing and submitting regulatory documentation, such as 510(k) submissions, premarket approval (PMA) applications, and de novo classification requests. Ensure the accuracy and completeness of your submissions and address any regulatory queries or concerns.
Regulatory Compliance: Provide guidance and expertise to help you understand and comply with relevant regulations, standards, and guidelines. The goal is to ensure that your medical devices meet all necessary requirements and obtain the required approvals or clearances.
Quality Management System (QMS): Assistance in establishing and maintaining a robust QMS that aligns with regulatory and quality standards. This includes developing customized processes, procedures, and documentation to ensure consistent production of safe and effective medical devices.
Audits and Inspections: Opportunity for internal audits of your quality system to identify any gaps or non-compliance issues. Available guidance and support during regulatory inspections or notified body audits, ensuring you are well-prepared and equipped to address any findings or observations.
Post-Market Surveillance: Establishing robust processes for post-market surveillance, including adverse event reporting, complaint handling, and vigilance activities. Compliance with post-market requirements, such as reporting adverse events to regulatory authorities and maintaining product safety and performance.
Training and Education: Tailored training sessions or workshops to educate your team on regulatory and quality requirements. The aim is to enhance your understanding of regulatory compliance and promote best practices in the medical device industry.
With expertise and guidance, Auxilium RQA is committed to helping you achieve regulatory compliance, maintain high-quality standards, and navigate the complexities of the medical device market successfully. Together, we will ensure the development, manufacturing, and distribution of your safe and effective medical devices.
Email: info@auxiliumrqa.com