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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.com. 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.

Our Strength for Accreditation System Consultancy

  • We have a team of highly- experienced ISO consultant and globally certified lead auditors for Consulting Services
  • Our team is having graduate/master degree of Engineering/management having more than 15+ years of experience in management system implementation for clients.
  • Our consultants provide handholding support to clients in development and implementation of policies, plans, controls, documentation and record-keeping as well.
  • 1000+ Accreditation System implementation in various industries in 15+ countries.
  • Implemented 7000+ Man-days Accreditation projects successfully
  • We follow the latest standard industry best practices for Accreditation implementation
  • 200+ Editable documents for various management systems have been sold to our global clients
  • 1000+ personnel of clients and other individuals trained by our consultants for awareness, system implementation and auditor training through online/class room.
  • Our accreditation consultants work with more than 50 leading International & National Certification Bodies such as BV; BSI; TUV; DNV; SGS; Lloyds; ISOQAR; NABL; IAS; UKAS, etc.
  • Our clients had got benefits of continuous improvements and business excellence with use of our practical approach in consultancy projects.
  • In our ready to use Accreditation documentation package we provide 150+ editable sample document templates with more than 400 pages.