Certification

For certain product categories of the fast-evolving drones technology, the global regions reacted by issuing certification frameworks. The EU released its drone regulation (EU 2019/947). As a Notified Body (NoBo, notification in progress) we globally provide our Clients with conformity assessment and certification of drones.

Certification

In critical and heavy duty services both human and technical elements need to be trusted, objectively quality assured. Third-party certification for persons, systems, processes and products is provided based on European and international accreditation, designation and notification credentials.

Certification

A vast majority of produced goods is intended for human interaction, elevating comfort, leisure, games, health or learning. Consumers shall be provided with safe & secure products. Certification of products is provided based on regulations and notifications of Europe, global standards and accreditations.

Certification

The entrance ticket to the international medical device market is an ISO 13485 certification. With our accreditations for ISO 13485 and ISO 27001, we provide internationally recognized certificates. In addition, we support our Clients throughout the certification stage with a Notified Body.

Clinical investigation

One of the keys to CE marking of medical devices is the validation of clinical safety and performance. With our team of doctors and biologists, we provide a full range of services from the design of clinical investi- gations, through the licensing to the preparation of a clinical investigation report.

Condition monitoring and testing

Laboratory and on-site testing, measuring of material, critical components, devices, industrial equipment, their impact for the environment, the verification of energy efficiency is required both authorities and is just common sense. We provide safety and conformity testing, or apply digital simulation, too.

Consulting

The continuous reinvention of human mobility requires the cooperation of various fields of consulting expertise with one target: timely, seamlessly comfortable, safe traveling & transport of goods! Our machinery safety, technology, cybersecurity and environmental engineers get involved as early-stage advisors, second or third-party experts.

Consulting

The innovation due to intensive competition for the satisfied Client and for the next „killer application” has ever been intensifying. So do the related risk management and consumer protection regulations. Our security by design, product safety, machinery & process safety, technology and environmental experts get involved as consulting experts.

Consulting

Compliance with the regulation of medical devices poses an increasingly difficult task for economic operators. In order to reduce the burden on economic operators, we provide full support for the CE marking of medical devices (MDR & IVDR), from regulatory strategy to post-market surveillance.

Critical infrastucture protection

The continuous, uninterrupted, uncompromised availability and granted in-service status of critical backbone elements of human erected infrastructure need protection against attacks and adversary actions from both the physical and the cyberspace. Our combination of deep knowledge of explosives and cyber risks prevails.

Cybersecurity evaluation

Connected autonomous vehicles, AGV's, AMR's, Drones with remote SW-upload, constantly communicating (V2X) represent a great opportunity, at the same time an equally great risk. The tackling of cybersecurity vulnerabilities is foreseen globally (EU 2018/58, ISO/SAE 21434, etc). We evaluate deeply the related cybersecurity aspects.

Cybersecurity evaluation

With the rise of permanent connectivity and digitalization industrial control systems (ICS) and networks are eminent subjects of mandatory assessment and validation of cybersecurity vulnerabilities. We execute cybersecurity (OT, IIoT) risk and compliance evaluation via global cybersecurity accreditations & standards.

Cybersecurity evaluation

With the rule of seamless connectivity (5G), sensing and data collection, AI-supported Applications & Products of the IoT category are obvious subjects of mandated validation of cybersecurity vulnerabilities. We evaluate cybersecurity under global (Common Criteria) and European (EU-CSA) frameworks.

Cybersecurity evaluation

Active and IVD devices which are connected, store any data, include any computing, control analog or digital functionality are subject to mandatory assessment and validation of cybersecurity risk. We execute cybersecurity evaluations based on the strictest accreditations and standards.

Education

The automotive industry has always been a segment with one of the strictest requirements with regards to the qualification of its people and processes. We provide education and training of related norms, regulations and sector-specific quality assurance methodologies in form of open, in-house or fully customized training.

Education

Industrial service requires trained personnel. We provide education and training of technical and quality assurance skills for construction, operation and maintenance of plants and equipment of energy, oil&gas, chemical, general production industries in the form that suits your needs: open, in-house or fully customized training.

Education

Serving people with safe products and software cannot be eventual. We provide education and training of technical prerequisites for CE marking, conformity of manufacturing processes, HSE aspects in the form that suits your needs: open, in-house or fully customized trainings.

Education

Fulfilling the requirements of CE marking is inconceivable without acquiring the appropriate knowledge. We provide training in all relevant areas related to CE marking of medical devices in the form that best suits your needs: open and outsourced or customized training.

Expert engagement

The essential project planning - feasibility - financial investment - construction progress supervision - commissioning - guarantee period value chain assumes the inherent “can I trust it really?” due diligence questions. Our conformity, machine safety, technology and environmental experts get involved as a second or third party.

Infrastructure digitalization

The Trusted Space concept assumes permanent sensing and data gathering related to people, various vehicle and infrastructure elements. The analysis and synthesis of the huge data volume contribute to decisions for intelligent traffic organization, energy efficiency, safer mobility culture. QTICS innovates conformity assessment services hereto!

Safety & Preclinical testing

Verification of medical devices safety is mandatory for all manufacturers. We provide safety tests according to IEC/EN 60601 and IEC/EN 61010 standards series, biocompatibility tests according to ISO 10993 standards series and usability testing and evaluation according to IEC/EN 62366-1 to verify the basic safety and the essential performance of active medical devices.

Safety and usability testing

Laboratory or on-site measurement and testing of materials, critical components, devices, industrial equipment, their impact on the environment, the verification of energy efficiency is required by both authorities and just by common sense. We provide safety and conformity testing and apply digital simulation, as well.

Smart Cities & Connectivity

People have started to realise the need for more climate protection but still human-centered structures. Connected devices and managed services, autonomous sub-systems shall contribute to a new balance both in the physical and the virtual space. Our intelligent city-level approach for local networks and communities prevails.

Verification, safety and usability testing

Let it be a component qualification, a test track, or an on-site test arrangement for determining environmental, functional, or safety behavior, we provide a wide range of accredited evaluation, homologation related and conformity assessment services.