qtec-group
qtec Services GmbH is a team of nearly 100 experts specializing in medical device approval, offering comprehensive support throughout the product lifecycle, including requirements engineering, risk management, software quality, verification & validation, clinical evaluation, registration, and post-market surveillance, with a focus on Medical Device Regulation (MDR). The company also provides specialized documentation services such as the development and management of technical documentation, development files, and medical device files, ensuring compliance with international standards like EN ISO 13485:2016 and US FDA requirements.
Industries
Nr. of Employees
medium (51-250)
qtec-group
Services
Consulting and documentation support for MDR/IVDR conformity assessment and CE marking.
Two‑step service: systematic gap assessment of TD/DHF/DMR with a Gap‑Assessment report, followed by project‑based remediation (e.g., new clinical evaluation, updated risk analyses, restructuring verification evidence) and delivery of updated documentation ready for submission.
Design, tailoring and implementation of QMS aligned to EN ISO 13485, 21 CFR 820 and other standards.
Preparation for regulatory audits and inspections, internal audits, mock‑inspections, supplier audits, on‑site accompaniment and remediation planning tailored to applicable standards and authority expectations.
Implementation of software lifecycle processes, software QA, and support for verification & validation and documentation for medical device software and SaMD.
Risk‑based validation of software used inside the QMS (ERP, DMS, in‑house applications) including requirements, test case definition and execution.
Consulting and documentation support for MDR/IVDR conformity assessment and CE marking.
Two‑step service: systematic gap assessment of TD/DHF/DMR with a Gap‑Assessment report, followed by project‑based remediation (e.g., new clinical evaluation, updated risk analyses, restructuring verification evidence) and delivery of updated documentation ready for submission.
Design, tailoring and implementation of QMS aligned to EN ISO 13485, 21 CFR 820 and other standards.
Preparation for regulatory audits and inspections, internal audits, mock‑inspections, supplier audits, on‑site accompaniment and remediation planning tailored to applicable standards and authority expectations.
Implementation of software lifecycle processes, software QA, and support for verification & validation and documentation for medical device software and SaMD.
Risk‑based validation of software used inside the QMS (ERP, DMS, in‑house applications) including requirements, test case definition and execution.
Expertise Areas
- Regulatory affairs (EU MDR/IVDR and international submissions)
- Quality management system design and ISO 13485 compliance
- Software lifecycle and SaMD compliance (IEC 62304)
- Design control, requirements engineering and traceability
Key Technologies
- IEC 62304 software lifecycle processes
- Structured data models for regulatory documentation (single‑source approaches)
- Software verification and validation (V&V) methodologies
- Risk management and device hazard analysis methods
News & Updates
Support in scientific documentation for technical files.
Latest trends, innovations, and regulatory requirements in medical software.
Understanding the UDI-DI and Eudamed DI/ID in medical device regulation.
Fundamentals and requirements of AI in medical devices under EU AI Act.
Support in scientific documentation for technical files.
Latest trends, innovations, and regulatory requirements in medical software.
Understanding the UDI-DI and Eudamed DI/ID in medical device regulation.
Fundamentals and requirements of AI in medical devices under EU AI Act.