ISO 14155:2020 – Good Clinical Practice (GCP) for Medical Device Clinical Investigations

What is ISO 14155:2020?

ISO 14155 certification is an internationally recognized standard that defines Good Clinical Practice (GCP) requirements for the design, conduct, recording, and reporting of clinical investigations involving medical devices. The standard ensures that clinical investigations are conducted ethically, scientifically, and in compliance with applicable regulatory requirements.

ISO 14155:2020 focuses on protecting human subjects, ensuring data integrity, and generating reliable clinical evidence to demonstrate the safety and performance of medical devices.

Importance of ISO 14155 Good Clinical Practice

Clinical investigations play a critical role in demonstrating that medical devices are safe and effective for their intended use. ISO 14155 Good Clinical Practice provides a harmonized framework accepted globally by regulators, manufacturers, and notified bodies.

Key objectives of ISO 14155 include:

• Protection of patient rights, safety, and well-being

• Ethical conduct of clinical investigations

• Scientific validity and data credibility

• Compliance with regulatory expectations

• Transparency and traceability of clinical data

Compliance with ISO 14155 is essential for manufacturers seeking regulatory approval in global markets.

Scope of ISO 14155:2020

Medical device clinical investigation GCP under ISO 14155 applies to:

• Pre-market and post-market clinical investigations

• Performance and safety evaluations

• Clinical follow-up studies

• Investigations involving human subjects

The standard covers all stages of a clinical investigation, from planning and design to reporting and record retention.

Key ISO 14155 Requirements

Understanding ISO 14155 requirements is critical for effective implementation. The standard emphasizes the following core elements:

1. Ethical Principles

Clinical investigations must follow ethical principles based on the Declaration of Helsinki, ensuring informed consent and subject protection.

2. Roles and Responsibilities

Clear responsibilities must be defined for sponsors, investigators, ethics committees, and monitors involved in clinical trials for medical devices ISO 14155.

3. Clinical Investigation Plan (CIP)

A well-structured CIP must be prepared, defining objectives, methodology, risk management, and data analysis procedures.

4. Risk Management

Risks associated with the medical device must be identified, evaluated, and controlled throughout the investigation lifecycle.

5. Data Management & Integrity

Accurate data collection, documentation, and record control are mandatory to ensure reliability and traceability.

ISO 14155 Certification Process

The ISO 14155 certification process typically involves:

1. Gap Analysis
   Review existing clinical investigation processes against ISO 14155 requirements.

2. System Development
   Develop procedures, templates, and clinical documentation.

3. Training & Implementation
   Train investigators, sponsors, and study teams on GCP principles.

4. Internal Review & Audit
   Conduct internal checks to ensure compliance.

5. Assessment & Certification
   Undergo external assessment to demonstrate conformity.

Who Needs ISO 14155 Certification?

ISO 14155 is essential for:

• Medical device manufacturers

• Clinical research organizations (CROs)

• Sponsors of clinical investigations

• Regulatory and compliance teams

• Healthcare institutions conducting device trials

Any organization involved in clinical trials for medical devices ISO 14155 should comply with this standard.

Business Benefits of ISO 14155 Compliance

• Improved patient safety and ethical compliance

• High-quality, credible clinical evidence

• Faster regulatory approvals

• Global acceptance of clinical data

• Reduced compliance and legal risks

• Enhanced reputation and trust

Meeting ISO 14155 requirements strengthens confidence among regulators and stakeholders.

Why Choose ISO 14155 Consultancy Services?

Professional consultancy helps organizations:

• Interpret complex regulatory requirements

• Develop compliant clinical investigation systems

• Train clinical and regulatory teams

• Prepare for audits and inspections

• Reduce delays and non-compliance risks

Expert guidance ensures smooth and efficient ISO 14155 implementation.

Frequently Asked Questions (FAQs)

1. What is ISO 14155 certification?

ISO 14155 certification confirms that clinical investigations of medical devices are conducted ethically and scientifically according to Good Clinical Practice.

2. Is ISO 14155 mandatory?

ISO 14155 is not legally mandatory but is widely required by regulators and notified bodies for clinical investigations.

3. Who should comply with ISO 14155?

Medical device manufacturers, sponsors, CROs, and organizations conducting clinical investigations must comply.

4. How long does ISO 14155 certification take?

Typically 3 to 6 months, depending on investigation scope and organizational readiness.

5. Does ISO 14155 apply to post-market studies?

Yes, ISO 14155 applies to both pre-market and post-market clinical investigations.