State of Art Quality
The high-quality expertise of the entire medical device life cycle – it is built into our services!
To ensure the safety and effectiveness of medical devices, the regulations have to be taken into account through the entire product life cycle. This requires deep understanding and knowledge of continuously changing regulations and standards – from these Innokas team has over 20 years of experience today.
From the early product specification and component selection phase to sales approvals, production processes, supplier control and even after-sales services, it is mandatory to know and follow the regulations related to each phase.
We are committed to ensure that high quality and regulatory requirements are met throughout the device whole lifecycle – just as our customers as well as the authorities require.
Our quality management system has ISO 9001:2015 and ISO 13485:2016 certificates as well as Canada ISO 13485:2003 certificate for design and manufacture of Medical Devices.
All sites have FDA registration as well.
Our products fulfill all the requirements, demands and needs that our customers and authorities have given to us. With our services we want to always exceed our customers expectations.
The quality, occupational health and security as well as environmental responsibility are important in all our operation. By implementing an environmental management system we want to ensure the satisfaction and co-operation with our customers, suppliers and stakeholders.
In all our operations at all our sites, we are committed to complying with applicable legal requirements as well as making continuous improvements. Based on these, we have set environmental objectives and targets and formulated programme to achieve them to reduce the environmental impact and prevent the pollution of the environment.