Overview of IEC 82304 Certification
IEC 82304 is applicable to the safety and security of all health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware and focus on manufacturers' requirements. It is applicable to the entire lifecycle, including design, development, validation, installation, maintenance, and disposal of health software products.
IEC 82304 fills the gap between the IEC 62304 and software medical device validation required by regulations. It contains a set of clauses defining the need at the system level, and it references existing state-of-the-art standards, i.e., ISO 14971 and IEC 62304 for the software level. IEC 82304 aims to provide the requirement for the safety and security of health software products.
Health Software products are software-only products. Such products are intended to be used with computing equipment not explicitly developed for running software. Such products are intended by their manufacturer for managing, maintaining or improving the health of individual persons or for delivery of care. IEC 82304 does not apply to health software that intends to become part of specific hardware designed for health use; however, the IEC 82304 does not apply to the followings:
Benefits of IEC 82304 Certification
The following are the benefits of having an IEC 82304 Certification:
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Perquisites for IEC 82304 Certification
IEC 82304 take reference from IEC 62304 in requirements, and sometimes it refers to the requirements from ISO 14971, but not mandatorily. The main requirements of IEC 82304 are as follows:
- Risk Management
- Legacy Software
- Software Development Process
- Software maintenance process
- Software risk management process
- Software configuration management process
- Software problem resolution process
- Risk Assessment of Health Software Product and Risk Mitigation actions (referred from ISO 14971)
Documents Section
Documents required for IEC 82304 Certification
Followings are the top most required documents and information for obtaining IEC 82304 Certification:
Procedure required for IEC 82304 Certification
These are the essential steps to be followed while obtaining IEC 82304 Certification:
- Optional Preliminary Audit
A voluntary Site inspection and review of quality management documents to assess the Organisation's readiness for the scale I and II Auditing Phase is done by the issuing authority.
- Audit: Stage I
Assessment of the eligibility for Certification is understood as well as determined by results of on-site Auditing, IEC 82304 standard documents analysis.
- Audit: Stage II
On-site evaluation of the compliance of the IEC 82304 standard for excellence in areas where practice and efficiency are applied completely.
- Certification
After completing all the above-mentioned steps, the Issuing authority certifies the IEC 82304 standard's integrity and compliance on the part of the Organisation and thus issues the IEC 82304 Certification.
Frequently Asked Questions
- Radiology Information System
- Prescription Management System
- Laboratory Information Management System
- Mobile Apps
- Corrective, such as fixing faults
- Adaptive such as adapting to new hard or software platform
- Perfective such as implementing new requirements
- Preventive such as making the product more maintainable.
- Software maintenance
- Revalidation
- Communication with interested parties
- Decommissioning and disposal
