ISO 13485 Certification
ISO 13485 certification to IVD manufacturers, IVD operators and sterilization service providers globally.
Sertio offers ISO 13485 quality management system certification to IVD notified body customers, operators in the IVD field and sterilization service providers.
ISO 13485 is a Quality management system standard developed to meet QMS requirements for regulatory purposes.
A condition for certification and certificate issuance is an audit to determine compliance to the specified quality management system standard 13485. The audit must conclude with a positive result. The independence, confidentiality and impartiality of the auditors is guaranteed by Sertio.
Two types certification service is available:
Initial certification , click to see more details and process description
Certificate transfer , click to see more details and process description
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Why 13485 certification?
For medical device organizations, compliance with ISO 13485 can support conformity assessment options that are used in different regulatory jurisdictions.
In many countries a quality management system is a regulatory requirement for IVD manufacturer.
ISO 13485 certification is often a prerequisite from the market point of view and serves as evidence of conformance to requirements.
The requirements of ISO 13485 are intended to act as a basis for demonstrating and supporting compliance with applicable regulatory requirements.
Disclaimer of liability:
The certification client remains responsible for the compliance with regulatory requirements and related deadlines. ISO 13485 certification service is not accredited.
All conformity assessment services are subject to availability.