Quality and Safety in Accordance with the Highest Medical Standards

Certificates and Quality Records

Here you will find current certificates and quality records for our products and processes.

Medical technology with certified precision and reliability

LAUDA Medical stands for precision, reliability, and uncompromising quality in medical technology. As a specialized manufacturer of temperature control devices for medical applications, we comply with the most stringent international standards and regulations. Our certifications document our commitment to quality, safety, and regulatory compliance in the medical environment.

Our systems are subject to regular audits and comply with international medical device standards. Download the required certificates here or contact us if you need further information.

Our Certifications

ISO 13485:2016

Quality Management System for Medical Devices

LAUDA Medical is certified to ISO 13485:2016 – the internationally recognized standard for quality management systems in the medical device industry. This certification confirms that our processes consistently fulfill the stringent requirements for the development, manufacture, and distribution of medical devices.
Available documents:

ISO 13485:2016 Certificate (German)
ISO 13485:2016 Certificate (English)

MDSAP

Medical Device Single Audit Program

Through MDSAP certification, LAUDA Medical simultaneously meets the regulatory requirements in the USA and Canada. This enables us to distribute temperature control devices for medical applications worldwide and provide optimal support to our customers in all relevant markets.

Available documents:

MDSAP Certificate

Why These Certifications Matter

Bright and modern medical laboratory or treatment room

For users of LAUDA Medical temperature control equipment in clinical settings, medical laboratories, and regulated industries, these certifications offer critical advantages:

Regulatory compliance: Fulfillment of international standards and statutory requirements
Process quality: Comprehensive documentation and complete traceability
Validation support: Assistance with qualification and validation processes
Worldwide acceptance: Seamless deployment in regulated medical markets
Patient safety: Highest quality standards for medical applications

All certificates are available for download as PDF files. The documents are updated regularly and reflect the current certification status.

Do you require additional documentation or have questions about our certifications?

Your contact at LAUDA Medical
Get in touch with us!

info@lauda-medical.com