Risk Management
Our Medical Team can provide expertise in developing and implementing Risk Management strategies for medical devices
Risk Management for medical devices involves systematically identifying, evaluating, and mitigating potential risks associated with the use of the device throughout its lifecycle. As your full-service compliance partner, Certification Experts can assist you with the Risk Management for your Medical Device(s). With over 25 years of experience, you can trust us to guide you to a compliant Risk Management.
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What is Risk Management?
Medical Device Regulations in Europe uphold strong emphasis on Risk Management on medical devices. Herein, manufacturers of medical devices must control risk mitigation measures throughout the design and production process. However, it is important to note that assessing the risks does not end here, as ISO 14971 compliance requires that companies manage risks as an ongoing internal process that lasts throughout a medical device’s product life cycle.
A Risk Management process consists of the following actions:
- Risk analysis
- Risk evaluation
- The implementation and verification of risk control measures
- The result of the evaluation of residual risks
What is ISO 14971?
The requirements described in ISO14971 are harmonised with the latest Medical Devices Regulations (MDR). The process intends to assist manufacturers of medical devices to identify the foreseeable hazards associated with the medical device, to estimate and evaluate the associated risks, to mitigate these risks, and to monitor the efficacy of the controls throughout all life cycle phases of the device. ISO14971 specifies that within this process manufacturers must also identify the hazards associated with medical devices, to estimate and evaluate the associated risks, to control and reduce these risks, to monitor the effectiveness of the controls, to evaluate residual risks and to perform reviews using production and post-production information. This also includes realising risks related to biocompatibility, data and systems security, electricity, moving parts, radiation and usability. Additionally, ISO 14971 requires that manufacturers establish objective criteria for risk acceptability, however the manufacturer must specify the specific acceptable risk levels herein.
Full-service Medical Device Regulation compliance
Key terms that are used in Risk Management
Some key terms that are used in Risk Management that are important to be aware of are:
When to start creating a Risk Management File
Creating a Risk Management file starts in the design and development phase. During this, manufacturers must already be assessing potential risks and which risk mitigation measures should be employed. During the production phase, it is also possible to identify potential risks, and both during and after the packaging and storage phases, they must be reviewed. If applicable, the transport phase may also need to be reviewed. Additionally, the post production phase is also of importance as post market surveillance must be conducted. Post market surveillance is necessary as the information obtained from this will be used as input for the Risk Management report.
Risk Management with Certification Experts
Certification Experts often encounter many customers who do not have their Risk Management in order when evaluating Technical Files. Herein, it is important to note that a Notified Body (NoBo) and manufacturer have the responsibility to check the efficacy of the Risk Management System. When a Risk Management system does not meet the requirements of the NoBo, a Corrective Action Preventative Action (CAPA) will be implemented immediately. This means an organisation shall take action to eliminate the causes of nonconformities in order to prevent a recurrence and to eliminate the causes of potential nonconformities in order to prevent their occurrence.
Certification Experts provide services for Risk Management and guidance with the Notified Body, along with support throughout the entire Medical Device Regulation process.
Full-service Medical Device Regulation compliance
All the answers you might need!
The Risk Management process for medical devices involves the creation of several key documents, including the Risk Management Plan, Hazard Analysis, Risk Assessment, documentation of Risk Control Measures, Verification and Validation Plans, Residual Risk Assessment, Risk-Benefit Analysis, Post-Market Surveillance Plan, User Manuals, Labeling, Traceability Records, Change Management Procedures, reports of Previous Incidents, records of Risk Management Reviews, and evidence of Compliance with Standards. Together, these documents form a comprehensive framework to identify, assess, and manage risks associated with a medical device, ensuring regulatory compliance and prioritizing patient safety.
In Europe, Medical Device Regulations place a significant focus on Risk Management for medical devices. Manufacturers are mandated to implement risk mitigation measures during the design and production processes. It is crucial to highlight that risk assessment is an ongoing process, as ISO 14971 compliance necessitates companies to continually manage risks throughout the entire product lifecycle.
A Notified Body plays, for most Classes within the Medical Devices, a crucial role in the Risk Management process for medical devices by independently assessing and verifying the manufacturer’s compliance with standards and regulatory requirements. This includes evaluating the effectiveness of Risk Management measures, ensuring ISO 14971 compliance, and facilitating ongoing surveillance to maintain regulatory approval. The Notified Body acts as a key intermediary with regulatory authorities and supports issue resolution, contributing to the overall safety and regulatory compliance of medical devices.
Risk Management is essential in the medical device industry to ensure patient safety, comply with regulatory requirements, enhance product effectiveness, assure quality, protect against legal and financial liabilities, facilitate post-market surveillance, build stakeholder confidence, promote continuous improvement, and gain a competitive advantage with global market access.
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