ISO 14155 Consultant for Good Clinical Practice in India

Our ISO 14155 consultants now offer ISO 14155 certification consultancy to organizations involved in the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.

ISO 14155:2020 is an International Standard which specifies Good Clinical Practices for Clinical Investigation of Medical Devices for Human Subject. The first edition of ISO 14155 standard was published in February 2003, and presently the third edition published in July 2020 is applicable for certification and regulatory purposes. ISO 14155 specifies general requirements intended to protect the rights and safety of human subjects to ensure the scientific conduct of the clinical investigation and the credibility of the results. The purpose of this standard is to define the responsibilities of the sponsor and principal investigator and assist sponsors, ethics committees, regulatory authorities, and other bodies involved in the conformity assessment of medical devices.

The ISO 14155 certificate is issued for a specific period after the successful completion of the final assessment. ISO 14155 certification demonstrates the organization's capabilities of developing an active approach to the Medical Devices for Human Subjects. ISO 14155 certification is crucial in proving a clinical investigation organization's ability for implementing good clinical practices.

To achieve this latest ISO 14155 certification, clinical investigation organizations can take help from our ISO 14155 Consultant who has rich experience in system implementation and certification based on ISO 14155 standard.

ISO 14155:2020 Certification

The ISO 14155 Certification consultancy service is provided in India by a team of ISO 14155 consultants of Punyam offers ISO14155:2020 certification services, which include support for implementation of a management system for Clinical Investigation of Medical Devices for Human Subjects as well as system documentation and system implementation training for all employees of the organization. Thus, our consultancy helps clinical investigation organizations to achieve quick and effective ISO 14155 certification from any approved ISO certification bodies in the USA, UK, Europe, Australia, etc.

Like other ISO management system certifications, ISO 14155:2020 Certification is desired by organizations that want to perform better. After an organization is audited for successful implementation of ISO 14155 system, certification body, which is accredited to provide ISO 14155 Certification, issues ISO 14155:2020 certificate. This certificate is issued for 3 years after successful completion of pre-assessment and registration (final) assessment. The certificate is valid for 3 years from the date of issue. Surveillance audits are conducted by the certification body within 3 years, at the intervals of 6 months, 9 months, or 12 months, depending on the nature and size of the organization. On completion of 3 years, renewal audit is done for new 3 years' cycle.

Steps of ISO 14155 Consultancy by

Following are the steps of ISO14155 consultancy followed by to implement a management system based on ISO 14155 and to achieve ISO 14155 certification:

  1. Conducting a Micro-level survey of the existing system and prepare a detailed Gap Analysis report for every activity of the organization,
  2. Forming a steering committee and preparing all applicable documents required by ISO 14155:2020, such as:
    • ISO 14155 manual
    • System procedures (mandatory procedures required by ISO 14155 standard)
    • Standard operating procedures (SOPs) to define safety and care precaution
    • Process approach
    • The complete strategic management plan
    • ISO 14155 Exhibits
  3. Effective implementation of ISO 14155 certification;
  4. Training to employees related to documentation and its implementation;
  5. Provide documentation and fine-tuning and implementation for every element of ISO 14155 certification;
  6. Training of internal auditors;
  7. Assessing the system through first internal audit to check readiness for the ISO 14155 certification,
  8. Taking corrective actions for nonconformities and carrying out management review meetings;
  9. Applying for ISO 14155:2020 certification;
  10. Conducting management review meeting in presence of Top Management to guide the organization for effective implementation of all the issues related to the Clinical investigation of medical devices;
  11. Taking corrective actions on the nonconformities to the satisfaction of the certifying body;
  12. Getting ISO 14155:2020 certificate.

Benefits of ISO 14155:2020 System

By implementing clinical investigation of medical devices as per ISO 14155:2020 standard, organizations can achieve the following benefits with continuous improvements:

  • Improved clinical practices and performances,
  • Effectively implemented system ensures scientific conduct of the clinical investigation and credibility of the clinical investigation results,
  • ISO 14155 based system assists sponsors, investigators, ethics committees, regulatory authorities, and other bodies involved in the conformity assessment of medical devices.
  • Protects the rights, safety, and well-being of human subjects,
  • Well-defined responsibilities of the sponsor and principal investigator;

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