ISO 14155 Consultant for Good Clinical Practice in India

Following are the steps of ISO14155 consultancy followed by Punyam.com 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.

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;

The key requirements of ISO 14155:2020 include the following:

• Application of Good Clinical Practice (GCP) principles and Quality management principles
• Ethics committee (EC) and Data monitoring committee
• Informed consent from subjects
• Clinical investigation plan (CIP), Investigator’s brochure (IB) and Case report forms (CRFs)
• Monitoring plan
• Clinical investigation in accordance with the CIP
• Written approval/favourable opinion from the EC and, if required, the relevant regulatory authority of the country
• Ongoing risk management throughout the clinical investigation
• Traceability of documents and data
• Access control of investigational devices
• Audits of the clinical investigation to evaluate compliance with the CIP, written procedures, and the applicable requirements
• Clinical investigation report after close-out of the clinical investigation
• A formal review of risk information upon completion of the clinical investigation
• Measures to prevent accidental or premature destruction of documents.