be-on-Quality
be-on-Quality GmbH is a company specializing in medical device compliance, regulatory affairs, and quality management. They support clients in market approval, risk management, and regulatory compliance, with a focus on MDR, ISO standards, and CE marking. Their mission is to ensure the safety and efficacy of medical products through expert consulting, testing, and documentation services.
Industries
Nr. of Employees
small (1-50)
be-on-Quality
Reichenschwand, Bayern, Germany, Europe
Services
Regulatory strategy, gap analyses, technical documentation updates, conformity assessment planning and support for CE marking and selected international submission pathways.
Design and implementation of QMS according to ISO 13485/ISO 9001/21 CFR 820, audit preparation, mock audits, supplier qualification and audit provision.
Development of clinical evaluation plans, systematic literature research, clinical evaluation documentation and support for clinical investigations and trials.
Test strategy development, test case and tool creation, system testing, product verification versus requirements, usability validation and validation of software and QMS tools.
Advisory services for medical device software quality, IEC 62304/62366 compliance, usability and model-based development using architecture modeling approaches.
Implementation of risk management systems per ISO 14971, documentation practices and supplier qualification procedures.
Regulatory strategy, gap analyses, technical documentation updates, conformity assessment planning and support for CE marking and selected international submission pathways.
Design and implementation of QMS according to ISO 13485/ISO 9001/21 CFR 820, audit preparation, mock audits, supplier qualification and audit provision.
Development of clinical evaluation plans, systematic literature research, clinical evaluation documentation and support for clinical investigations and trials.
Test strategy development, test case and tool creation, system testing, product verification versus requirements, usability validation and validation of software and QMS tools.
Advisory services for medical device software quality, IEC 62304/62366 compliance, usability and model-based development using architecture modeling approaches.
Implementation of risk management systems per ISO 14971, documentation practices and supplier qualification procedures.
Expertise Areas
- Regulatory compliance for medical devices (MDR/IVDR/CE, FDA 510(k))
- Quality management systems (ISO 13485, ISO 9001, 21 CFR 820)
- Risk management for medical devices (ISO 14971)
- Clinical evaluation and clinical investigations
Key Technologies
- ISO 13485 QMS implementation
- ISO 14971 risk management
- MDR/IVDR technical documentation and conformity assessment
- Clinical evaluation methodologies (literature review, CE reports)