Punyam.com recently announced of starting a new certification consultancy service for the ISO 14155 system for good clinical practices for clinical Investigation of medical devices for a human subject. The first edition of the 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 planned to protect the rights and safety of human subjects to ensure the scientific conduct of the clinical investigation and the credibility of the results. This standard determines to describe the responsibilities of the sponsor and principal investigator and assist sponsors, ethics committees, regulatory authorities, and other bodies that are involved in the conformity assessment of medical devices.
Punyam offers ISO 14155 certification services that include support for the 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. ISO 14155 Certification is desired by organizations that want to perform better. After an organization is audited for successful implementation of the ISO 14155 system, the certification body, which is accredited to provide ISO 14155 Certification, issues ISO 14155 certificate. This certificate is issued for 3 years after successful completion of pre-assessment and registration 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 3 months depending on the nature and size of the organization.
Applying clinical investigation of medical devices as per ISO 14155 standard the organizations can achieve the benefits with continuous improvements are like ISO 14155 certification helps to improve clinical practices and performances, successfully implemented system to ensures scientific conduct of the clinical investigation and credibility of the clinical investigation results, The ISO 14155 protects the rights, safety, and well-being of human subjects, and it well-defined responsibilities of the sponsor and principal investigator.
About Punyam.com â€“ India
Punyam.com, a leading ISO consultancy company in India, provides ISO implementation, documentation, auditor training as well as management training. Punyam has implemented ISO 22000, ISO 37001, ISO 15189, ISO 17020, ISO 17024, ISO 13485, SA8000, FSSC 22000, ISO 44001, ISO 22716, ISO 41001, BRC, GMP, CE mark, and many more associated quality standards in all industries since 1991. Punyam has small and big size manufactures and services provider organizations as a list of satisfied clients in India. For more details visit our web portal at www.punyam.com