Products
Our products and services enable companies in regulated industries to respond more quickly to changing circumstances.
compliag compliance framework
Governance, compliance and
end-to-end traceability
An artefact-based quality management system for the development of medical devices in Switzerland and the EU. Includes version control, document issuance and end-to-end traceability.
from CHF 600 per month
Learn morecompliag compliance framework
Processes, methods, tools and language models for the manufacture of medical devices.
Functionalities
- Modelling of organisational structures, processes and tasks
- Modelling of systems and system components
- Predefined structures for a quick start, including regulatory requirements
- End-to-end traceability
- Integrated risk analysis
- Single source of truth for all process- and product-related information
- Easy access to model information for external stakeholders
- Review and approval process
- Version management
- Export to freely definable document formats
Your benefits
- Identification and prevention of inconsistencies
- Rapid response to changes
- Dependencies arising from changes visible at a glance
- Clear documentation for audits and inspections
Particularly suitable for
- Manufacturers of medical devices
Strategic consultancy on compliance, security and governance
Structured advice.
Regulatory certainty.
Support in translating complex regulatory requirements into structured, secure and auditable systems and processes.
from CHF 180 per hour
Learn moreStrategic consultancy on compliance, security and governance
Strategic consultancy and operational support for compliance, security and governance in regulated industries
We help organisations translate complex regulatory requirements into structured, secure and audit-ready systems and processes.
Our consultancy combines: regulatory expertise, structured business modelling, systematic risk analysis, robust documentation and audit-compliant governance.
The result is transparent, secure and sustainable organisational and product structures.
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Governance, compliance and
end-to-end traceabilitycompliag compliance framework
An artefact-based quality management system for the development of medical devices in Switzerland and the EU. Includes version control, document issuance and end-to-end traceability.from CHF 600 per month
-
Structured advice.
Regulatory certainty.Strategic consultancy on compliance, security and governance
Support in translating complex regulatory requirements into structured, secure and auditable systems and processes.from CHF 180 per hour
We offer you
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Regulatory expertise
We are familiar with the relevant laws, regulations, norms and industry standards applicable to your sector, and we translate abstract legal texts into concrete, actionable requirements. In doing so, we keep an eye not only on the current state of affairs, but also on how it is evolving. -
Structured Business Modelling
Complex organisations can only be managed effectively if their structures are made visible. We model business processes, organisational units, roles, responsibilities and system landscapes in such a way that the interrelationships remain clear and manageable, even when their number runs into the thousands. -
Systematic risk analysis
Risks arise at the interfaces between processes, systems and areas of responsibility. We systematically identify, assess and prioritise these risks, and ensure that risk management is not a one-off project but an integral and dynamic part of the organisation. -
Comprehensive documentation
If something isn’t documented, it might as well not exist in an emergency. We establish documentation structures that ensure guidelines, work instructions, records and incidents are kept consistent, versioned and easily retrievable. -
Audit-compliant governance
Governance becomes apparent the moment it is scrutinised. We design governance structures, control mechanisms and audit trails in such a way that responsibilities, decision-making processes and the results of controls can be fully traced at all times. -
Integrated documentation and record-keeping
Technical documentation, system and operational documentation, and audit trails are maintained in a structured manner and updated on an ongoing basis. Support with risk analyses, audit preparation and inspections ensures that regulatory requirements are not only met but can also be demonstrated.
-
Regulatory expertise
We are familiar with the relevant laws, regulations, norms and industry standards applicable to your sector, and we translate abstract legal texts into concrete, actionable requirements. In doing so, we keep an eye not only on the current state of affairs, but also on how it is evolving.
-
Structured Business Modelling
Complex organisations can only be managed effectively if their structures are made visible. We model business processes, organisational units, roles, responsibilities and system landscapes in such a way that the interrelationships remain clear and manageable, even when their number runs into the thousands.
-
Systematic risk analysis
Risks arise at the interfaces between processes, systems and areas of responsibility. We systematically identify, assess and prioritise these risks, and ensure that risk management is not a one-off project but an integral and dynamic part of the organisation.
-
Comprehensive documentation
If something isn’t documented, it might as well not exist in an emergency. We establish documentation structures that ensure guidelines, work instructions, records and incidents are kept consistent, versioned and easily retrievable.
-
Audit-compliant governance
Governance becomes apparent the moment it is scrutinised. We design governance structures, control mechanisms and audit trails in such a way that responsibilities, decision-making processes and the results of controls can be fully traced at all times.
-
Integrated documentation and record-keeping
Technical documentation, system and operational documentation, and audit trails are maintained in a structured manner and updated on an ongoing basis. Support with risk analyses, audit preparation and inspections ensures that regulatory requirements are not only met but can also be demonstrated.
Reducing complexity
Please contact us for an initial discussion about the benefits and possibilities of the compliag compliance framework.