Components
The artefact-based QMS is available in various configurations.
eQMS Basis
Processes and work instructions as the basis for a QMS that is robust in regulatory terms.
from 300 CHF per month
Learn moreeQMS Basis
Core processes and work instructions in accordance with ISO 13485, the EU MDR and the MepV
Scope of the product
- Document control and versioning
- Process map in accordance with ISO 13485
- Work instructions for core processes
- Templates for evidence and records
Your benefits
- Ready-to-use, coordinated processes and work instructions
- Regulatory affairs expertise is already included in the package
- A ready-to-use foundation for a QMS
Particularly suitable for
companies that are setting up their QMS from scratch or wish to establish it on a robust regulatory footing.
eQMS Pro
A set of rules tailored to your organisation, designed to suit your products and existing processes.
from 800 CHF per month
Learn moreeQMS Pro
Customised processes, roles, policies and guidelines
Scope of the product
- Customised process and role models
- Company-specific guidelines and instructions
- Alignment with existing systems and processes
- Customised templates and forms
Your benefits
- Templates and content tailored to your business
- Familiar terminology, without sacrificing the benefits of the eQMS
Particularly suitable for
Companies with established but not fully documented processes, which are looking for a tailor-made QMS rather than a standard solution.
eQMS Advanced
A bespoke set of rules and a representation of all operational artefacts.
from 2,000 CHF per month
Learn moreeQMS Advanced
All processes, work instructions, individual sets of rules and operational results required for a medical device manufacturer to operate in compliance with regulations.
Product range
- Results and evidence
- Risk management
- Non-conformities (CAPA)
- Products and Product Files
- Projects
- Directory of staff
- IT infrastructure
- Application portfolio
Your benefits
- Consistent documentation
- Faster adaptation of processes, products and organisational structures
- Integrated risk management
- Reduction in manufacturing costs, liability risks and development time
Particularly suitable for
companies wishing to bring their medical devices to market more quickly and assess changes more rapidly.
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eQMS Basis
Processes and work instructions as the basis for a QMS that is robust in regulatory terms.
from 300 CHF per month
-
eQMS Pro
A set of rules tailored to your organisation, designed to suit your products and existing processes.
from 800 CHF per month
-
eQMS Advanced
A bespoke set of rules and a representation of all operational artefacts.
from 2,000 CHF per month
Your benefits
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Single Source of Truth
Each piece of information exists only once and forms the common basis for all documentation, decisions and audits. -
End-to-end traceability
All dependencies are clearly visible: from regulatory requirements through to business objectives, organisational units, individuals, suppliers, products, system architectures, test cases, systems and test results, right through to risks. This means it is always possible to trace why a particular piece of information exists, what decision it is based on, and what impact a change would have. -
Integrated risk management
Risks are an integral part of any piece of information, whether it relates to a system component, a requirement or a manufacturer.
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Single Source of Truth
Each piece of information exists only once and forms the common basis for all documentation, decisions and audits.
-
End-to-end traceability
All dependencies are clearly visible: from regulatory requirements through to business objectives, organisational units, individuals, suppliers, products, system architectures, test cases, systems and test results, right through to risks. This means it is always possible to trace why a particular piece of information exists, what decision it is based on, and what impact a change would have.
-
Integrated risk management
Risks are an integral part of any piece of information, whether it relates to a system component, a requirement or a manufacturer.
