Motek Medical is proud to announce achievement of the ISO 13485 with CMDCAS accreditation. Acquiring these certifications is the culmination of years of hard work, consistent top-quality products, and the commitment and dedication of our entire staff. Not only has it helped us improve our internal processes, but it clearly demonstrates our commitment to improvement, service and quality to our customers and markets.

Motek Medical’s Quality System obliges the requirements of the EN ISO 13485:2003 standard, the European Medical Device Directive (93/42/EEC Annex II), the US Quality System Regulations (21 CFR part 820) and the Canadian Health Medical Device Regulation (MDR) so that we can optimally serve our clients in the medical device industry, for which this standard is a prerequisite. With this Quality System we present our commitment to quality to our clients, potential clients and all stakeholders in the company. Working in a field in which standards, guidelines and regulations are changing rapidly, we also make sure that our quality management system updates with these changes. Key in our philosophy is to maintain and improve the quality management system to the highest standards.

We believe that our decision to become ISO 13485 Certified is a proactive one that not only anticipates the demands of our clients, but also demonstrates our commitment to providing quality services to all our clients.