Expertise.
Verification and Validation.
Guarantee the quality and regulatory compliance of your products.
Structured?
Do your V&V processes ensure product safety and regulatory compliance?
Secure?
Are your V&V processes optimized to save time and resources?
Efficient?
Do your V&V processes provide clear traceability for audits?
Ensure your product quality through efficient verification & validation.
Verification & Validation - Structured processes for quality and compliance.
Our service offers you comprehensive support in ensuring product quality and compliance with regulatory requirements.
Verification & Validation (V&V) are crucial processes to ensure that products meet all regulatory requirements and comply with the highest quality standards. Our tailor-made solutions support you in effectively designing verification and validation processes, minimizing risks and optimizing product development. We guide you through all phases of verification and validation, from planning to implementation and documentation.
Our services include:
- Verification and validation planning: Creation of detailed V&V plans to ensure that all relevant processes are monitored and documented.
- Test procedures and risk management: carrying out tests to verify and validate your products and implementing comprehensive risk management
- Regulatory compliance: Ensuring that all verification and validation processes comply with applicable regulatory requirements.
Verification & Validation Services at a glance.
Our services support you in ensuring product quality and compliance with regulatory requirements.
Verification and validation planning.
- Creation of detailed plans for the verification and validation of your products
- Ensuring complete documentation of all V&V processes
- Establishing milestones and monitoring progress in product development
Test procedures and risk management.
- Carrying out verification and validation tests to ensure the safety and effectiveness of your products
- Implementation of a risk management system for the early detection and minimization of potential risks
- Documentation of test results to ensure traceability
Regulatory compliance.
- Ensuring compliance with regulatory requirements, such as ISO 13485 and 21 CFR Part 820
- Preparation for audits and official inspections
- Support in preparing the necessary documentation for submission to the authorities
Successful projects in the area of verification & validation.
Our projects help companies to ensure the quality of their products and at the same time meet regulatory requirements.
Introduction of a comprehensive V&V system for a medical technology company
Optimization of validation processes for a biotechnology company
Implementation of a verification and validation system for a pharmaceutical company
Challenge.
A medical technology company had to ensure that its products met the requirements of the FDA and the European MDR.
Measures.
- Implementation of a V&V system to ensure compliance with ISO 13485 and 21 CFR Part 820
- Carrying out verification and validation tests to assess product quality
- Training the team on the correct implementation of V&V processes
Results.
- Improved traceability and product quality
- Successful preparation for FDA audits and MDR compliance
- Long-term optimization of product development processes
Success.
The company was able to meet the regulatory requirements and successfully obtain market approval for its products.
Ensure the quality and compliance of your products with our V&V services.
Our service portfolio.
Our Verification & Validation portfolio offers comprehensive solutions for optimizing your verification and validation processes and ensuring product quality.
Our experts create detailed plans for the verification and validation of your products and ensure that all processes are fully documented. We set clear milestones to make progress in product development transparent.
We carry out comprehensive verification and validation tests to ensure the safety and effectiveness of your products. Our risk management system enables us to identify potential risks at an early stage and take preventive measures.
Our services ensure that your verification and validation processes comply with the applicable regulatory requirements. We prepare you for audits and official inspections and assist you in preparing the necessary documentation.
We implement automation solutions to make the verification and validation process more efficient and ensure quality. Automated workflows improve traceability and reduce manual errors.
Our experts implement risk-based validation methods to ensure that your products meet the highest safety standards. This minimizes risks and ensures the quality and compliance of your products.
We offer training courses and workshops for your team to ensure that everyone involved understands the V&V requirements and regulatory specifications and implements them efficiently. In this way, we contribute to the quality assurance and compliance of your products.
Optimize your product quality and compliance.
Related topics for ensuring product conformity.
These supplementary services help you to comprehensively check the functionality and compliance of your products:
