Certification

Reliability and quality are crucial in the medical field and part of the DNA of Lode. By prioritizing quality, we not only enhance the reliability of our devices but also build trust with healthcare professionals and patients alike. Our focus on certified products ensures that we deliver innovative solutions that meet the highest industry standards, fostering confidence in our brand and the life-saving
technologies we provide. Quality isn’t just a goal; it’s a commitment to the future of healthcare. Lode products are RoHS/WEEE compliant and Lode is ISO 9001:2015, and ISO 13485:2016 certified.

Our medical devices comply with the requirements of the MDD or MDR and therefore proudly display the CE mark.

ISO

Lode is ISO 13485:2016 and ISO 9001:2015 certified.

MDR

The European Union has changed their Medical Device Directive into a law which is called the Medical Device Regulation (MDR). This change was initiated in order to better control the medical device quality and therefore the safety of the patient. Lode BV fully supports this goal and we are proud that our organisation meets the MDR requirements. This is crucial for our mutual business.

Code of Conduct
Medical Devices

On January 1, 2012, the Code of Conduct Medical Devices entered into force. The Code provides rules for suppliers of medical devices and healthcare professionals. Lode fully supports this code of conduct and acts accordingly.

CE

We are proud that Lode products are CE certified, which signifies that our medical devices meet the rigorous safety, health, and environmental protection standards set by the European Union.

International standards

International certifications are crucial for successful market expansion in foreign countries. Our company complies with multiple international standards and regulations, ensuring that our products meet the highest safety and quality requirements globally. We are certified under MDR and our QMS is certified through MDSAP. Furthermore we are compliant with FDA regulations and meet many local standards.