Quality system

Mar-Med Co. strives to achieve the optimal product standards by applying the techniques of continuing improvement.  We put resources toward a manufacturing process that satisfies a variety of existing quality frameworks.  Through customized quality controls, documentation and assurance procedures, Mar-Med Co. can guarantee that our products attain the desirable high-quality levels to ensure the health and safety of our customers.

Mar-Med Co. develops its own quality control and assurance procedures to optimize our compliance with national and international regulations.  Our comprehensive quality assurance program includes:

• Injection mold qualification and validation process,

• Incoming inspection and monitoring of all raw materials,

• In-process monitoring and verification of manufacturing process,

• 100% FQC and sampling OQA and testing,

• Sterilization in facilities that meet ISO13485 and EN550 standards,

• Adherence to FDA, ISO 13485:2003 quality standards, and CE marking requirements,

• Compliance with Medical Device Vigilance Reporting standards,

Chris Morrell, Vice President of the National Standards Authority of Ireland notes that, “By having ISO 13485 certification, those who use the Tourni-Cot product can have peace of mind in the quality of Mar-Med Co’s manufacturing and continuous improvement processes. We at NSAI hope that this certification opens up new markets for their Tourni-Cot product.”