Expertise.
Risk management.
Identify and minimize risks with tailor-made solutions for the pharmaceutical and medical technology industry.
Unsure?
Are your current risk management processes clearly structured and up to date?
Unpredictable?
Do you want to ensure that all potential risks are identified and assessed at an early stage?
Complex?
Do you need support in implementing a comprehensive risk management system?
Secure your products through effective risk management.
Risk Management - Comprehensive risk analysis and compliance.
Our risk management service helps you to identify potential risks at an early stage and minimize them through preventive measures.
The identification and assessment of risks are crucial to ensure the safety and compliance of your products in the pharmaceutical, biotechnology, IVD and medical technology sectors. Our risk management solutions help you to implement the necessary processes to meet regulatory requirements such as ISO 14971.
Our services include:
- Risk analysis: Identification and evaluation of potential risks along the entire product life cycle.
- Risk minimization: Development of preventive and corrective measures to reduce risks.
- Compliance management: Ensuring compliance with regulatory requirements in accordance with international standards.
Risk Management Services at a glance.
Our risk management solutions cover all key areas of risk identification, assessment and minimization.
Risk analysis.
- Identification of potential risks in all phases of the product life cycle
- Assessment of risks according to probability of occurrence and severity
- Regular review and updating of risk analyses
Risk minimization.
- Development of preventive measures to reduce risk
- Implementation of corrective measures to eliminate existing problems
- Monitoring the measures to ensure their effectiveness
Compliance Management.
- Ensuring compliance with international risk management standards such as ISO 14971
- Support with documentation and preparation for official audits
- Regular training courses and workshops to raise risk awareness
Successful risk management projects in the life science industry.
Our projects help companies to identify risks at an early stage and minimize them through preventive measures.
Implementation of a risk management system for a medical technology company
Optimization of risk management for a pharmaceutical company
Implementation of a risk monitoring system for a biotechnology company
Challenge.
A biotechnology company needed a system for the continuous monitoring and evaluation of potential risks in production.Measures.
- Implementation of a risk monitoring system for the real-time recording of risks
- Development of action plans for risk mitigation
- Introduction of a monitoring system to track security incidents
Results.
- Early detection of potential risks and rapid response
- Improved product safety through preventive measures
- Reduction of security incidents by 20 % in the first year
Success.
The company was able to increase product safety and efficiently fulfill regulatory requirements.Optimize your risk management and secure your products.
Our service portfolio.
Our risk management portfolio supports you in identifying, assessing and minimizing risks to ensure the safety and compliance of your products.
Our experts identify potential risks at every stage of the product life cycle and assess them according to probability of occurrence and severity. We use proven methods and tools to identify and monitor all relevant risks at an early stage. Further information on regulatory requirements can be found in the ISO 14971 guidelines and the FDA Guidance on Risk Management.
We develop preventive and corrective measures to effectively minimize existing risks. Our solutions include the implementation and continuous monitoring of action plans that help to reduce potential security incidents. Visit our Risk Management page for more details.
Our services ensure compliance with international risk management standards such as ISO 14971. We support you in creating documentation, preparing for regulatory audits and conducting training. Find out more about regulatory requirements on the EMA website.
Secure your products with comprehensive risk management.
Related topics for effective risk management.
These supplementary services help you to systematically identify, assess and minimize risks in your projects, processes and supply chains:
