Risk Identification Analysis & Control - Software - ISO 13485

ISO 13485 - QMS.4.1.6.3- QT - Risk Identification Analysis & Control - Software

Our Medical Device Quality Assurance and Regulatory Affairs document templates have been created by fully qualified and experienced professionals at Patient Guard, a Quality Assurance and Regulatory Affairs Service provider. The templates have been specially written to ensure that they meet the basic requirements needed for each clause/section of the standard or regulation the templates relate to. We have carefully curated the templates to ensure they are easy to follow and adapt to make them specifically modified to your business needs. All the templates are fully editable Microsoft word documents allowing you to have complete control over the templates which, then be modified to suit your company branding/marketing requirements.

When do we need to preform software risk assessment?

• If the use of a piece of software is deemed to have related risks, the known and foreseeable hazards associated with the use of the software should be identified.
• The potential harm and probability of occurrence associated with the identified hazards should be analysed.
• Risk mitigation actions should then be considered and implemented.

Which clause within the ISO 13485 standard will this template help our company comply to?

• The software risk analysis and control template will aid your compliance to Clause 4.1.6 which states; “The specific approach and activities associated with software validation and re-validation shall be proportionate to the risk associated with the use of the software.”

Do we require any supporting documents?

• Additional templates that may be of interest to you include QMS.4.1.6 - QP - Software Validation and Re-validation Procedure, QMS.4.1.6.2 - QR - Software Acceptance Testing Plan and Record and QMS.4.1.6.1 - QR - Master Software List.

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.

Quality Management Support:

If you are looking for support with your QMS then Patient Guards consultancy services could be a cost effective solution for your organisation.