Audit-ready. International. Permanently up to date.
QM System 5.0 with Update Service
Regulatory Requirements change. Your Quality Management System must keep pace.
The QM System 5.0 from regular services is not a generic document package, but an audit-proven, internationally aligned Quality Management System built on real Regulatory
Requirements . It is immediately implementable, flexibly configurable, and permanently compliant with the integrated Update Service.
A Quality Management System that truly works – and stays up-to-date.
Many Quality Management Systems are formally correct but barely usable in daily practice. Our system is different: it is based on international Regulatory Requirements, proven in practice, and structured so that audits bring no surprises. And with the integrated Update Service, it becomes truly complete – because we do not just provide information, we incorporate the solution directly.
What the QM System 5.0 with Update Service includes
Select individual Standard Operating Procedures, assemble a package tailored to your company – or use the complete system. We’ll support you to ensure that the system includes precisely the processes relevant to your product, your portfolio, and your organization.
Covered regulations
The system does not only cover European requirements – it is internationally oriented:
- ISO 13485:2016
- ISO 14971:2019
- Regulation (EU) 2017/745 (MDR)
- Regulation (EU) 2017/746 (IVDR)
- European QM guidelines (MDCG)
- International QM guidelines (IMDRF)
- US 21CFR820 (QMSR)
- And many more
Included Standard Operating Procedures
Theme
DE
EN
Quality Management Manual
✓
—
Control of Regulations
✓
✓
QM System Software Validation
✓
✓
QM System Planning
✓
✓
Design Control
✓
✓
Risk Management
✓
✓
Prozessvalidierung
✓
✓
Marketing CE Area
✓
✓
Marketing Rest of World
✓
✓
Marketing USA
—
✓
Marketing Canada
—
✓
Medical Device Software Development
✓
✓
Supplier Management
✓
✓
Clinical Evaluation Management
—
✓
Biological Evaluation
—
✓
Case Management
✓
✓
CAPA
✓
✓
Post-Market Surveillance
✓
✓
Vigilance CE Area
✓
✓
Vigilance Rest-of-World
—
✓
Vigilance Canada
—
✓
Vigilance USA
—
✓
All Standard Operating Procedures are available individually or as a package – and are adapted to your company-specific requirements if necessary.
What makes the difference – the QMS Update Service
- Quarterly updates of changed Standard Operating Procedures and templates
- Regulatory Monitoring included – no separate research needed
- Best practices and audit feedback are directly incorporated
- Audit-readiness without any maintenance effort on your part
A Quality Management System is only as good as its latest version. Regulatory Requirements change – new standards, updated guidelines, changed requirements. Other providers inform you about these changes. Regular services integrates the solution directly into your system.
In practical terms, this means: when a new standard becomes relevant for one of your processes – such as software validation – we update the corresponding Standard Operating Procedure directly. You do not receive a task – you receive a complete solution.
The QMS Update Service is only available in combination with the regular services QMS.
All Update Services at a glance:The right system for your company.
Whether individual Standard Operating Procedure, tailored package, or complete system with Update Service – we’ll find out together what works for you.
Schedule a free initial consultationOur services
Our customers
Medical Device
manufacturers
Start-ups
Suppliers for medical devices / IVD
Authorities
IVD manufacturers
Investors
Frequently Asked Questions about the QM System with Update Service
Yes. According to the MDR, the obligation to maintain a QM system for all medical device manufacturers – regardless of Product Class. Manufacturers of Class I products must also demonstrate a documented QM system. ISO 13485 is the only harmonized standard intended to fulfil this requirement. With our QM System, you start with a compliant foundation – ready for immediate use.
A Quality Management System according to ISO 13485 comprises all documented Standard Operating Procedures and templates that a Medical Device manufacturer needs for safe and compliant process operations – from development through manufacturing to Post-Market Surveillance. Our QM System covers ISO 13485, MDR/IVDR, and relevant MDCG guidelines – and goes beyond the European framework: with coverage of the US QMSR (21 CFR Part 820), international QM guidelines (IMDRF), and MDSAP requirements, it is also suitable for manufacturers with international ambitions.
→Covered regulations
Surveillance Audits take place annually; Recertification Audits every three years. What matters is that the system is continuously maintained between audits – not just shortly before. This is exactly what the Update Service is designed for.
In many cases, yes. Whether a complete rebuild makes sense or existing structures can be adopted will be determined together in an initial consultation. We adapt the scope to your situation – no unnecessary additional effort.
The Regulatory Update Service identifies new or changed standards, guidelines, and regulations – and informs you which of these are relevant for your product and Quality Management System. Implementation is up to you.
The QMS Update Service goes one step further: it is available exclusively in combination with the QM System from regular services and incorporates regulatory changes directly into your Standard Operating Procedures and templates. You receive the complete solution – not just the notification.
Every three months, we review which regulatory changes are relevant for your Quality Management System – and implement them directly in your system. You do not receive a list of tasks – you receive an updated solution. No maintenance required on your part. No surprises at the next audit.
Building a QMS from scratch takes months. Our ready-to-use, audit-proven system can be implemented straight away – and remains up to date at all times thanks to the Update Service. See for yourself whether it’s right for you.