Risk management serves as the cornerstone of our system, guiding the development of our processes and products. It is an integral component of regulatory, quality, and clinical evaluation strategies. Through its systematic application, implementation, and outcomes, we can demonstrate the safety and efficacy of our products and services. This ensures they operate as intended, with their benefits far outweighing inherent risks.
Regulatory bodies mandate medical device risk management throughout the product lifecycle, from conception to post-market surveillance, within the framework of your entire Quality Management System (QMS).
Our team possesses extensive expertise in applying risk management across various device types within diverse manufacturing settings. We offer independent or collaborative services to formulate and execute risk management plans tailored to your specific product requirements. We adhere to relevant standards, with ISO 14971 forming the foundation of our risk management processes.
Our services:
- Development of risk management plans and reports
- Conducting risk assessments utilizing methodologies such as ISO 14971, Failure Mode and Effects Analysis (FMEA), IEC 60601, ISO 10993, and ISO 62366-1 (for usability engineering application)
- Inspection and audit of manufacturing environments and equipment
- Providing recommendations for optimizing manufacturing workflows and implementing effective risk mitigation strategies
- Conducting audits and qualification of contract manufacturers and vendors
- Maintenance of QMS and risk management files post-registration, including Corrective and Preventive Actions (CAPA), complaints, and Adverse Events (AEs)
