ISO/TR 24971:2020 certification furnishes guidance to assist manufacturers in implementing, maintaining, and developing risk management systems for medical devices that are intended to meet the requirements of the ISO 14971:2019 standard, Application of risk management to the medical device. “TR” means “Technical Report.” It gives guidance on the application of ISO 14971:2019 standards for various types of medical devices. These medical devices contain implantable and non-implantable, active and non-active medical instruments; software as medical machines; and in vitro diagnostic medical devices.
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ISO/TR 24971:2020 Certification – Medical Devices
ISO 14971:2019 Certification is the current version of the medical device risk management system, delivering manufacturers a holistic method of assessing, controlling, and identifying the hazards associated with medical devices. The ISO TR 24971:2020 Certification is the technical report or companion document for ISO 14971. You can look at it as an equal to one of the FDA’s suggestion records—the objective of the technical information is to give the reader extra context and details about specific parts of the standard with which it is associated.
General Requirements For Risk Management System
[A]. Risk Management Process
This standard requires the manufacturer to implement, establish, maintain, and document a continuous hazard management method throughout the life cycle of a medical machine. The essential elements in this procedure and the obligations of the highest management are determined in ISO 14971:2019 and explained in detail in this certification.
[B]. Management Responsibilities
Top Management commitment
Top management has the responsibility for maintaining and establishing an effective hazard management method. The emphasis on the highest management in ISO 14971:2019 certification is significant. Top management can delegate authority and obligations, set preferences, and give resources within the association. Commitment to the highest grade of the association is necessary for the hazard management procedure to be effective.
The Policy of Establishing Criteria for Risk Approvability
This certification requires the highest management to specify and document a policy to establish measures for risk approval. The policy may permit specific measures for each type of medical instrument. This may depend on the features of the medical machine and its planned usage(casting the intended patient residents). This standard is the policy to give guidelines on establishing measures for the acceptability of the overall residual hazard.
[C]. Suitability of the Risk Management Procedure
Under this certification, the highest management must examine the suitability of the hazard management technique at planned intervals. The suitability assessment is a high-level check of the hazard management procedure and may contain a review of the following aspects.
Personnel Qualification: Confirming the appointment of competent workers is the obligation of top management. Measures of workers who may be involved in specific hazard management processes and who have the related experience and knowledge to effectively achieve the respective functions.
[D]. Risk Management System
The risk management system defines the scope of risk management activities, the authorities and responsibilities of the people involved, the hazard acceptance measures, the post-production and production information to review and collect for the medical machine, and all risk management actions to perform throughout the life cycle. The risk management system can be a separate record, or it can integrate with other documents, such as quality management method documents.
Scope of The Risk Management System:
The scope describes and identifies the medical device and the life cycle steps to which each feature of the plan applies.
Distribution of Authorities and Responsibilities:
The risk management system specifies personnel or functions responsible for completing specific actions related to hazard management.
Need For Review of Hazard Management Actions:
The risk management process specifies functions or personnel responsible for completing precise activities related to risk management.
Risk Acceptability Criteria:
Risk acceptance measures are established under the manufacturer’s procedure to determine acceptable hazards. This contains criteria for situations where the possibility of harm cannot be estimated, in which case hazard acceptance measures may be based solely on the severity of harm.
System for Assessing the Overall Residual Risk and the Approval Criteria: The system for assessing the overall residual risk and the acceptance criteria for it are derived from the manufacturer’s procedure for establishing hazard acceptance measures. The process and criteria must be stated in the hazards management plan for the particular medical instrument under development under the ISO 14971:2019 standard.
The Verification Activities: The risk management system specifies how the two verification actions required by this standard are carried out. The hazard management method can describe the verification actions explicitly or via reference to other methods.
Actions Related to the Review and Collection of Post-Production and Production Information: This standard requires the manufacturer to establish a system for actively reviewing and collecting information about the medical instrument in the post-production and production stages and checking this knowledge for relevance to security.
[E]. Risk Management File
This standard requires the manufacturer to maintain and establish a risk management file, which contains other documentation and records created during risk management activities for a medical device throughout its life process, from initial concept to last disposal.
Required Documents For ISO/TR 24971:2020 Certification
- System Manual of Medical Device Manufacturing Company
- System Procedure of Medical Device Manufacturing Company
- Policy of Medical Device Manufacturing Company
- Objectives of Medical Device Manufacturing Company
- Mission & Vision of Medical Device Manufacturing Company
- SOP of a medical device manufacturing Company
- Checklist of Medical Device Manufacturing Companies
- Forms of Medical Device Manufacturing Companies
- Formats of Medical Device Manufacturing Company
- Records of Medical Device Manufacturing Company
- Size of the medical device manufacturing Company
- Activities performed via a medical device manufacturing Company
- Processes undertaken via a medical device manufacturing Company
- Products and services offered via a medical device manufacturing Company
Who Can Get ISO/TR 24971 Certification?
Companies involved in the implementation, maintenance, and development of a risk management system for medical devices can obtain ISO/TR 24971 certification. And medical device manufacturers also obtain this certification.
How to Get ISO/TR 24971:2020 Certification?
Apply: In the first stage, apply for ISO/TR 24971:2020 Certification.
Document Review: You will supply proof of the applicant’s medical device manufacturing organization and the name of the medical device manufacturing organization. All information of the medical device manufacturing association and related records and documents to the certification body for review.
Audit: In this step, an offline or online audit is done successfully, and all the systems and activities of the medical device manufacturer organization are checked.
Certificate: In this step, you get ISO/TR 24971:2020 certification.
ISO/TR 24971:2020 Certification Consultancy
A Star Legal Associates provides ISO 24971 certification consultancy services for medical device manufacturers in India. Contact our team for more information at 93143-21001.
Conclusion
ISO/TR 24971 certification is very important for medical device manufacturers. it guides manufacturers in implementing, maintaining, and developing a management procedure for all medical devices.
