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What is ISO 14155?

ISO 14155:2020 is a globally recognized standard that governs good clinical practices for medical device clinical investigations involving human subjects. It is applicable to manufacturers, sponsors, clinical research organizations (CROs), and investigators engaged in medical device testing for pre-market and post-market studies.

This standard ensures that:

  1. Clinical trials are scientifically sound and ethically conducted
  2. The rights, safety, and well-being of human subjects are protected
  3. Data collected is credible and reliable for regulatory submissions

ISO 14155 is harmonized with international regulatory bodies such as the EU Medical Device Regulation (EU MDR) and the US FDA, making it vital for global market entry and compliance.

Why is ISO 14155 important?

With growing emphasis on patient safety and ethical research, regulatory authorities now demand more robust clinical trial documentation and processes for medical devices. ISO 14155:2020 bridges the gap between ethical clinical practices and business compliance.

You should adopt ISO 14155 if:

  1. Your medical devices require pre-market clinical trials
  2. You aim to conduct multi-national clinical investigations
  3. You want to align with GCP requirements recognized by regulatory authorities
  4. You need to build a trustworthy reputation among stakeholders, regulators, and patients
  5. You plan to reduce delays in regulatory approvals due to non-compliance

Growth Management Corporation provides complete support from gap analysis to certification readiness, making your clinical research system audit-proof and globally compliant.

What are the benefits of ISO 14155?

Implementing ISO 14155:2020 brings a wide range of benefits, including:

  1. Enhanced clinical trial quality through standardized procedures
  2. Improved ethical oversight of human subject research
  3. Reliable and reproducible results that support regulatory submissions
  4. Clear documentation trails that reduce audit risk
  5. Compliance with EU MDR and FDA expectations
  6. Minimized patient risk and improved participant recruitment confidence
  7. Global harmonization with GCP standards for international market access
  8. Stronger risk management integrated into trial planning and execution


What kind of businesses can benefit from ISO 14155?

ISO 14155:2020 certification and implementation offer measurable value to your medical device business. Key business advantages include:

  1. ✅ Faster Market Approval: Ensures data integrity, increasing chances of regulatory approval in the first review cycle
  2. ✅ Global Expansion: Opens access to global markets by aligning with international GCP standards
  3. ✅ Brand Reputation: Enhances trust with investors, healthcare professionals, and patients
  4. ✅ Operational Efficiency: Streamlines clinical investigation processes and documentation practices
  5. ✅ Risk Reduction: Prevents costly trial failures and regulatory penalties
  6. ✅ Investor Confidence: Demonstrates a commitment to compliance and quality, attracting funding
  7. ✅ Compliance Preparedness: Positions your company for successful audits and inspections by authorities like ISO bodies, FDA, or notified bodies
  8. ✅ Ethical Leadership: Shows your commitment to patient safety and data transparency


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