Certification of

Certification

Quality is one of the most important characteristics of the Lode brand. Certification is critical for a company operating in the medical device industry to showcase its commitment to quality, safety, and compliance with regulatory requirements, and Lode is dedicated to meeting these standards. All Lode products are RoHS/WEE compliant and Lode is ISO 9001:2015, and ISO 13485:2016 certified. All medical products comply to MDD 93/42/EEC, incl. IEC 60601-1.

ISO Certification

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 is ready to meet 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. You can download the last amended version of January 2017 here.