CRConsultants
CRConsultants GmbH & Co. KG specializes in supporting manufacturers of medical devices and machinery by helping them develop safe products and processes through regulatory compliance and technical solutions. They focus on areas such as machine safety, medical product safety, management systems, and technical documentation, aiming to ensure safety, compliance, and efficiency in product development and manufacturing.
Industries
Nr. of Employees
small (1-50)
CRConsultants
Products
Standardized technical documentation templates
Pre-structured documentation templates aligned with the Machines Directive and applicable norms to accelerate preparation of technical files and manuals.
UDI compliance checklist and labeling templates
Checklist and template components to support UDI data preparation, packaging labeling updates and EUDAMED registration workflows.
Standardized technical documentation templates
Pre-structured documentation templates aligned with the Machines Directive and applicable norms to accelerate preparation of technical files and manuals.
UDI compliance checklist and labeling templates
Checklist and template components to support UDI data preparation, packaging labeling updates and EUDAMED registration workflows.
Services
Development of safety concepts, CE documentation and operator documentation for machinery, including integration of usability and risk reduction measures.
Support for creation and maintenance of regulatory documentation (MDR/IVDR), qualification and validation support, and implementation of vigilance and post‑market surveillance processes.
Implementation and tailoring of ISO 9001, ISO 13485, ISO 27001 and ISO 17025 management systems and integrated management approaches to support certification and accreditation.
Internal audits, gap analyses, and preparation and accompaniment for external audits and regulatory inspections including readiness planning and response support.
Design and optimization of regulated product development and support processes including risk management, software lifecycle processes, CAPA, change control and hygiene monitoring.
Advisory and implementation support for information security management, data protection measures and ISMS required for digital health applications and program-specific submissions.
Development of safety concepts, CE documentation and operator documentation for machinery, including integration of usability and risk reduction measures.
Support for creation and maintenance of regulatory documentation (MDR/IVDR), qualification and validation support, and implementation of vigilance and post‑market surveillance processes.
Implementation and tailoring of ISO 9001, ISO 13485, ISO 27001 and ISO 17025 management systems and integrated management approaches to support certification and accreditation.
Internal audits, gap analyses, and preparation and accompaniment for external audits and regulatory inspections including readiness planning and response support.
Design and optimization of regulated product development and support processes including risk management, software lifecycle processes, CAPA, change control and hygiene monitoring.
Advisory and implementation support for information security management, data protection measures and ISMS required for digital health applications and program-specific submissions.
Expertise Areas
- Machine safety and CE conformity
- Medical device regulatory compliance (MDD/MDR/IVDD/IVDR)
- Quality management systems and accreditation (ISO 9001, ISO 13485, ISO 17025)
- Information security and data protection for digital health (ISMS, ISO 27001, national guidance)
Key Technologies
- ISO 13485 quality management
- ISO 9001 quality management
- ISO 27001 information security (ISMS)
- BSI IT‑Grundschutz (national information security framework)
News & Updates
An article explaining the 6S-Audit method to improve efficiency and safety through workplace organization.
A blog post discussing how to ensure future-proofing of machines by considering component discontinuation in specifications.
Information about updates and removals of harmonized standards related to PPE under EU regulation 2016/425.
Details about the revision of the ISO 14644-3 standard for cleanrooms and its implications.
An article explaining the 6S-Audit method to improve efficiency and safety through workplace organization.
A blog post discussing how to ensure future-proofing of machines by considering component discontinuation in specifications.
An article explaining the 6S-Audit method to improve efficiency and safety through workplace organization.
A blog post discussing how to ensure future-proofing of machines by considering component discontinuation in specifications.
Information about updates and removals of harmonized standards related to PPE under EU regulation 2016/425.
Details about the revision of the ISO 14644-3 standard for cleanrooms and its implications.
An article explaining the 6S-Audit method to improve efficiency and safety through workplace organization.
A blog post discussing how to ensure future-proofing of machines by considering component discontinuation in specifications.