ISO 13485 Audits

ISO 13485:2016 is the internationally recognized quality management system suitable for the design and development, production, installation and service of medical device as well as related services in the design, development and provision of related industries. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.

The benefits of obtaining ISO 13485 certification:

• Improve your process quality and transparency.
• Ensure quality, safety and performance of your medical devices.
• Expand the global market.
• Raise brand reputation.
• Enhance consumer confidence and satisfaction in your product.
• Avoid costly product recalls by delivering consistent quality and safety.

The use of ISO 13485 certification:

• In the U.S., the Food and Drug Administration (FDA) permits device manufacturers to submit ISO 13485 audit reports as a substitute of the evidence of compliance with its quality systems regulations (QSR).
• In some markets, such as the European Union and Japan, medical device manufacturers must obtain ISO 13485 certification.

STEMart helps manufacturer assess the conformity of their medical device to the requirements of iso 13485 before it can be placed on the market.

What We Do

An ISO 13485 audit includes:

• An off-site review of your current quality and regulatory documentation before your on-site ISO 13485 audit by a Notified Body or Registrar.
• A systematic and independent process audit to determine conformity or nonconformity of your QMS to ISO 13485:2016 requirements.
• A review of your internal and external documentation to verify requirements have been addressed.
• An actual verification of ISO 13485 audit requirements through a review of the objective evidence.
• A physical verification of compliance via interviews and fact-based observations to confirm the quality system requirements are met.
• An evaluation of current special controls and validated processes. Emergo consultants are knowledgeable in various processes such as sterilization, clean rooms, or software systems.

STEMart provides a ISO 13485 audit for medical device manufacturer to help them gain access to global markets. If you want to learn more detail about our service, or would like to consult with the experts at STEMart, please feel free to contact us.