ISO14971 Audits for Chinese Medical Device Factories

Risk management is critical for medical device safety. Angelstar Consulting delivers specialized ISO14971 medical device risk management audits for Chinese medical device manufacturers, aligning with FDA and CE MDR requirements. Our audits cover risk analysis, evaluation, control, and review, helping you identify and mitigate product risks and ensure medical device safety.

How do we carry out our ISO14971 medical device risk management audit services for Chinese medical device factories and suppliers?

1： Medical Device Risk Management Scope Definition & Standard Alignment

Before the official ISO14971 audit, our experts work with Chinese medical device factories to define the audit scope, covering the entire lifecycle of medical devices (design and development, production, distribution, post-market surveillance). We align your risk management system with ISO 14971：2019 standards and global medical device regulations (FDA QSR, CE MDR), and review your risk management documents, including risk analysis records, risk evaluation reports, and risk control measures.

2： On-Site Medical Device Risk Management Audit

On-site audits focus on verifying the implementation of ISO14971 requirements: risk analysis (identification of hazards and hazardous situations), risk evaluation (assessment of risk severity and probability), risk control (implementation of risk reduction measures), risk-benefit analysis (evaluation of risk acceptability), and post-market surveillance (monitoring of medical device safety in the market). Our auditors review risk management records for your medical devices, interview risk management personnel to assess their professional competence, and verify the effectiveness of risk control measures.

3： Risk Management Compliance Report & Rectification Guidance

A detailed ISO14971 audit report is issued within 5 working days, including risk management assessment results, non-conformity identification (e.g., incomplete risk analysis, lack of post-market surveillance), and targeted rectification solutions. Our experts help you optimize your medical device risk management system, such as implementing a standardized risk analysis process or enhancing post-market surveillance procedures. We conduct a follow-up audit to ensure full compliance with ISO14971 standards.

4： Global Medical Device Market Access Support

We provide long-term post-audit support: updating your risk management system based on the latest ISO14971 standard revisions and medical device regulations, providing risk management training for your staff, and assisting in preparing for medical device registration (e.g., FDA 510(k), CE MDR certification). Our services help Chinese medical device factories ensure product safety, meet global market access requirements, and enhance their product competitiveness.

ISO14971 Audits: Third-party risk management verification for Chinese medical device enterprises to meet FDA, CE MDR requirements.