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QTICS Medical is an intelligent service group composed by companies that support different stages of medical device manufacturers' conformity journey. The participating companies complement each other’s expertise, services and create a unique, smart and integrated solution of conformity services. Thanks to our wide medical device related capabilities and accreditations, clients can enjoy the comfort of our expertise. We can safely and swiftly guide all kind of medical device manufacturers through the labyrinth of conformity. We have a great pool of experts to review existing or compile new MDR/IVDR technical documentations, medtech-related quality management systems with the necessary training provided. We provide various required preclinical tests (safety, biocompatibility, cybersecurity ones) and manage complete clinical investigations. Additionally, we have an engineering section providing embedded and medical software development and testing. Our advantage lies in the combination and collaboration of various experts (e.g. engineers, medical doctors, biologists, chemists and software developers) whose knowledge is crucial for the proper implementation. So far almost 100 companies trusted us and used our integrated services to reach CE conformity successfully.
In case you have any question around medical device conformity, request a free initial consultation at medical@qtics.group
MAIN SERVICES
CONFORMITY ASSESMENT SUPPORT (MDR/IVDR/FDA) |
EDUCATION |
PRODUCT AND SOFTWARE DEVELOPMENT |
PRECLINICAL AND PRODUCTION EQUIPMENT TESTING |
CLINICAL INVESTIGATION |
CERTIFICATION |
| Support on classification | Quality Management system | Turnkey product development | Usability testing | Clinical investigation plan | Quality management system |
| Identification of applicable other legal requirements | MDR/IVDR training | PCB design | Software validation | Preparation of Submission Package | Management systems |
| GAP analysis | MDR/IVDR related standards | Embedded Software development | Safety testing | Authorisation support | Information security management |
| Implementation of QMS | Customised MD related training | Software development | Biocompatibility testing | Conducting and monitoring | GDPR |
| Internal audits | Clinical investigation | AI System integration | Cybersecurity testing | Data management | |
| Preparation of Strategy for Regulatory Compliance | PRRC | ROHS testing | Prepare clinical investigation report | ||
| Identification of reqirements for preclinical testing | UDI | ||||
| Technical documentation preparation | HTA | ||||
| UDI design | AI | ||||
| Registration of manufacturer and device |
The conformity assessment and the certification shall be performed by the independent Notified Bodies, officially registered by the European Commission. They can be reached at the following links:
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Memberships
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International Business Partners
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References
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.
Read moreEducation
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.
Read moreCertification
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.
Read moreCybersecurity 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.
Read moreClinical 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.
Read moreSafety & 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.
Read more