What IEC 62304?
IEC 62304 is a functional safety standard that covers safe design and maintenance of software. It provides processes, activities, and tasks to ensure safety. It applies to the development and maintenance of medical device software when: The software is itself a medical device.
Is IEC 62304 mandatory?
IES 62304/2006 may be employed in technical reports (technical dossiers). It is currently not mandatory to be certified on that standard.
What are the applicable life cycle process for IEC 62304?
Software Development Process
- development planning.
- requirements analysis.
- architectural design.
- detailed design.
- unit implementation and verification.
- integration and integration testing.
- system testing.
- release.
What is medical device single audit program?
The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.
Is SDLC a framework?
The software development lifecycle (SDLC) is a framework that development teams use to produce high-quality software in a systematic and cost-effective way. Both large and small software organizations use the SDLC methodology.
What is a Class 1 medical device?
Class 1 medical devices are devices with low or moderate risk to patient health and safety. 47% of approved medical devices are Class 1, and 95% of these devices are exempt from the PMA pathway to regulatory approval. Class 1 device manufacturers are required to register their device with the FDA, however.
What is a Class B medical device?
Class B – this classification is for medium risk in vitro diagnostic devices. A conformity assessment by a Notified Body is required for this classification.
How are medical devices classified in general?
Medical device classification based on risk Class Is (sterile device) = Low risk. Class IIa = Medium risk. Class IIb = Medium to high risk. Class III = High risk.
What is the difference between Mdsap and ISO 13485?
ISO 13485 MDSAP are two different programs with similar requirements but they do not duplicate each other. MDSAP has the more stringent requirements of the two and companies that are already certified to ISO 13485 will see an increase in the number of audit days once they seek certification to MDSAP.
What is ISO 13485 certified?
ISO 13485 was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes. It ensures the consistent design, development, production, installation and delivery through to disposal of medical devices that are safe for their intended purpose.