ISO 14155 - Clinical investigation of medical devices for human subjects -

 

What is ISO 14155?

ISO 14155 outlines good clinical practices for clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. It features general requirements intended to protect the rights and safety of human subjects and to ensure the scientific conduct of the clinical investigation and the credibility of the results.

This standard also defines the responsibilities of the sponsor, principal investigator, and other bodies involved in the conformity assessment of medical devices.

Once certified, organisations can proudly promote themselves as certificate holders in any of their promotional materials and can include the URS certification logo free of charge.

 

Who requires ISO 14155?

ISO 14155 is a requirement for organisations involved in the clinical trials of medical devices. Including but not limited to the manufacturers of medical devices.

How can ISO 14155 benefit your business?

Becoming certified for ISO 14155 can bring a wide range of benefits to your organisation, including:

 

• Ensuring the protection of human subjects


• Conducting good clinical practice


• Assuring reliable conduct during the course of clinical trials

How can you prepare for ISO 14155?

Although the thought of starting the certification process may seem daunting, there are a variety of steps you can take to make the process to becoming certified far more streamlined:

 

• Familiarise yourself with the ISO 14155 standard


• Undertake Good Clinical Practice training for yourself and other members of staff to increase your understanding of the standard


• Gather customer feedback on your current complaint handling process


• Ensure that you have implemented a Quality Management System that aligns with ISO 14155 requirements


• Carry out regular internal audits to identify gaps in compliance and assess for readiness.

What are the key requirements for ISO 14155?

When working towards becoming certified for ISO 14155, there are various areas that will be a focus during the audit. These areas include:

 

• Subject protection


• Clearly defined roles


• Compliance with ethical review processes


• Documentation and reporting

What clauses make up the structure of ISO 14155?

 

 

Clause 1-3 – Introductory Clauses:

The first three clauses in ISO 14155 serve as an introduction to the standard and outline the scope, normative references and the terms and definitions. This also includes a brief exploration of the standard’s history, approach and compatibility with other standards.

The seven remaining clauses cover the mandatory good clinical practice requirements surrounding the clinical investigation of medical devices for human subjects.

Clause 4 – Summary of good clinical practice principles

Clause 4 outlines an extensive list of principles that must be followed to ensure that best practice is met at all times. This touches on medical care, consent, and investigational device specifics.

 

Clause 5 – Ethical considerations

Clause 5 concerns itself with any areas where ethical requirements are put into place. This includes improper influence, responsibilities, communication with the ethics committee, and vulnerable populations.

 

Clause 6 – Clinical investigation planning

Clause 6 focuses on planning processes related to investigations and the document control that accompanies it. Sub sections in this clause include; risk management, investigation plans, and case report forms.

 

Clause 7 – Clinical investigation conduct

Clause 7 provides requirements for the conduct of investigations and ensures that all clinical investigations are carried out as per the Clinical Investigation Plan. This section also explores documentation control and the recording of data.

 

Clause 8 – Suspension, termination, and close-out of the clinical investigation

Clause 8 regards all circumstances where a clinical investigation would come to an end. This includes suspensions, terminations and the closing out of an investigation. Throughout this section, subclauses such as procedures, reports and risk assessments are also covered.

 

Clauses 9 – Responsibilities of the sponsor

In the largest section of the standard, clause 9 outlines the requirements, expectations and responsibilities of a sponsor involved in clinical investigations. These responsibilities include clinical quality management, planning and conduct, and the outsourcing of duties.

 

Clauses 10 – Responsibilities of the principal investigator

In the final section of the standard, clause 10 follows the same suit as the previous clause and explores the responsibilities of the principal investigator. Each requirement is covered, from qualifications and communication, to compliance with the CIP

 

How long will your ISO 14155 certificate be valid for?

Your ISO 14155 certificate will be valid for at least three years; dependent on the type of site that is being certified.  

 

Ready to get started? Apply using the quotation link below.