What is the current version of IEC 62304?

The second version of IEC 62304 is still in draft. It has been is this state for almost five years, since the publication of the amendment 1. It is now in public review (or has been in public review in your country) under the name IEC 62304:2019 CDV.

What are the applicable life cycle processes 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 the classification of medical devices?

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 are the main focuses of the IEC 62304 standard?

IEC 62304 focuses on the software development process, defining the majority of the software development and verification activities.

What is the current version of ISO 14971?

ISO 14971:2019
Today there are three versions of ISO 14971: ISO 14971:2007, EN ISO 14971:2012 and ISO 14971:2019. EN is the ISO standard for the European market. Everywhere else in the world ISO 14971:2019 remains the current standard.

What is a Class 3 medical device?

Class III – These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.

What is the difference between Class 1/2 and 3 medical devices?

FDA Medical Device Classifications Class I: A medical device with low to moderate risk that requires general controls. Class II: A medical device with a moderate to high risk that requires special controls. Class III: A medical device with high risk that requires premarket approval.

What does IEC stand for?

The Electoral Commission of South Africa (often referred to as the Independent Electoral Commission or IEC) is South Africa’s election management body, an independent organisation established under chapter nine of the Constitution.