IEC 62304 Training in Karachi, Lahore, Islamabad,Pakistan, Dubai

IEC 62304 Training

IEC 62304 is an internationally harmonized standard for medical device software lifecycle processes, recognized by FDA and other regulatory agencies across the world. IEC 62304 provides guidance to the manufacturer on planning, development, and postmarket surveillance activities for medical device software to ensure companies are in compliance with both. An earlier release of IEC 62304 was less clear, but a 2006 amendment to the standard clarifies the requirements. IEC 62304:2006 provides guidance to manufacturers on how to identify hazards that could arise from software failure or defect, in order to properly classify the risk of a medical device. Based on the device risk classification, IEC 62304 provides guidance for risk control measures that must occur throughout the life cycle of that particular device.

WHY IS IT IMPORTANT?

In the EU, the requirements of ISO 13485 have been harmonised with the essential requirements of the EU’s Medical Device Directive (93/42/EEC), the Directive for In Vitro Diagnostic Medical Devices (98/79/EC) and the Directive for Active Implantable Medical Devices (90/385/EEC). Certification to ISO 13485 by an accredited certification body provides a presumption of conformity with the essential requirements of these important directives. In the U.S., the Food and Drug Administration (FDA) permits device manufacturers to submit ISO 13485 audit reports as a substitute of the evidence of compliance with its quality systems regulations (QSR). Health Canada also requires medical device manufacturers marketing their products in Canada to have their quality management system certified to ISO 13485

Course Outline

1.Scope.

2.Normative references

3.Terms and definitions.

4.general requirements.

5.Software development process.

6.Software maintenance process.

7.Software risk management process

8.Software configuration management process

9.Software problem resolution process.

What Is IEC 62304 Certification?

It’s easier to get certified for compliance when you have the right development tools. And it’s even easier when those tools have already been certified by an independent organization.

Helix QAC, for instance, is certified by SGS-TÜV Saar for use in the development of safety-critical systems. While Klocwork has been certified by TÜV-SÜD for functional safety compliance. Both can be supplied with a tool certification kit, which makes the path to compliance much simpler.

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