Own Certifications

At SINOVO, we took care of our own certifications, i.e. ISO 9001 and ISO 13485 for the certification of our quality management systems, at an early stage and applied for an EC certificate, which is necessary for placing medical devices on the market. In addition, our information security management system (ISMS) is certified in accordance with ISO 27001. ISO 27001 is the leading international standard for ISMS and therefore the most important cyber security certification.

Our own certifications are particularly important to us for our customers so that we can guarantee you consistently high quality.

But proven quality is not good enough for our customers. We therefore use our QM system to continuously improve and develop our processes and product quality.

All our business and development processes are subject to constant quality control and are documented in detail. Derived measures are implemented, and the system is practised throughout the company daily.

EC CERTIFICATE TO PLACE MEDICAL SOFTWARE ON THE MARKET

Our EC certificate for a complete quality management system in accordance with the Medical Device Regulation 2017/745 authorises us to place medical devices on the market.

Thanks to our many years of experience and industry-specific expertise in the field of medical software, we cover medical software in risk classes I, II a and II b and all conformity assessment procedures to be applied depending on the risk class in accordance with the Medical Device Directive.

A complete quality management system, in our case in accordance with ISO 13485, means that we fulfil the additional requirements of the directive for market surveillance, reporting, document retention, etc., and that our medical software conforms to the directive. Our EC certificate also confirms that we have a quality management system for our production, testing and final inspection, which also covers the final inspection of our products.

Conformity with the Medical Device Directive is a mandatory requirement for the CE labelling of our medical software for access to the European single market.

With the CE marking, we as the manufacturer express that our medical software fulfils the essential requirements of a European directive, e.g. the Medical Device Regulation EU 2017/745. Medical software may not be placed on the market in the European Union without CE labelling.

CE labelling is therefore not a purely formal act, but a mandatory step in a higher-level process, the conformity assessment procedure.

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MAKING PROVEN QUALITY EVEN BETTER

But proven quality is not good enough for our customers. At SINOVO, we use our quality management system to continuously improve and develop our processes and product and service quality. Each of our employees has a high level of quality awareness and sees their customers as the recipients of their personal performance. All SINOVO staff receive regular training to ensure that the high-quality expectations of our customers are met.

QUALITY CONTROL OF ALL SOFTWARE IMPLEMENTATION PROCESSES

All software implementation processes, from task clarification to maintenance of the implemented system and support services, are subject to constant quality control and are documented in detail. Derived measures are evaluated and implemented. The ‘plan, implement, check, act’ process specified by the standard is practised throughout the company every day.