Industries.
Design Controls.
Ensure that your product development meets the highest quality and regulatory requirements.
Structured?
Are your design controls structured in such a way that they ensure clear processes for product development?
Compliant?
Do your development processes meet the regulatory requirements?
Efficient?
Are your products developed and tested promptly and without any loss of quality?
Ensure the quality of your product development with structured design controls.
Design Controls.
Our Design Control Services support you in establishing structured development processes to ensure that your products meet regulatory requirements and comply with the highest quality standards.
Design controls are crucial to ensure the quality and safety of products, especially in medical technology. We offer customized solutions to help you manage your product development efficiently and ensure that all regulatory requirements are met. Our experts support you from planning to risk assessment and market launch to ensure the compliance and quality of your products.
Our services include:
- Process planning and structuring: Establishing clear processes for monitoring product development to ensure that all phases are documented in a traceable manner.
- Risk management and testing: Conducting risk assessments and implementing suitable test procedures to identify and minimize potential risks at an early stage.
- Regulatory compliance: Ensuring that all development processes comply with relevant standards and regulations, including ISO 13485 and 21 CFR Part 820.
Design Controls Services at a glance.
Our Design Controls Services offer you comprehensive support in structuring and monitoring your product development processes.
Process planning and structuring.
- Detailed planning and documentation of product development processes
- Establishment of monitoring mechanisms to ensure quality in every development phase
- Implementation of clear control processes to fulfill regulatory requirements
Risk management and testing.
- Carrying out risk assessments throughout the entire development process
- Implementation of test procedures to identify potential risks at an early stage
- Documentation and monitoring of tests to ensure product quality
Regulatory compliance.
- Ensuring compliance with ISO 13485, 21 CFR Part 820 and other relevant regulations
- Preparation for audits and official inspections
- Support in the preparation of documentation for submission to the authorities
Successful projects in the field of design controls.
Our Design Controls projects help companies to ensure the quality of their products while meeting regulatory requirements.
Introduction of design controls for a medical technology company
Optimization of product development for a biotechnology company
Implementation of a risk management system for a pharmaceutical company
Challenge.
A pharmaceutical company needed to ensure that its design controls met EU and US regulatory requirements and that effective risk management was implemented.
Measures.
- Development and introduction of a risk management system for risk assessment throughout the entire development process
- Implementation of test methods for early detection of potential risks
- Training the team to implement and monitor the design controls
Results.
- Improved risk assessment and early detection of potential problems
- Improving product quality and compliance with international regulatory requirements
- Long-term improvement of product development processes
Success.
The company was able to secure its product development processes and significantly minimize development risks.
Ensure the quality of your product development with structured design controls.
Our Design Controls Service Portfolio.
Our Design Controls portfolio offers comprehensive solutions to optimize your product development processes and ensure regulatory compliance.
Our experts support you in the detailed planning and documentation of your product development processes. We implement clear control mechanisms to ensure that all phases of your development are documented transparently and comprehensibly.
We carry out risk assessments throughout the entire development process and implement suitable test procedures to identify potential risks at an early stage. Our methods guarantee seamless monitoring and documentation to ensure product quality.
Our design control services ensure that your development processes meet the requirements of ISO 13485, 21 CFR Part 820 and other regulatory requirements. We prepare you comprehensively for audits and official inspections and support you in preparing the necessary documentation.
We use lean methods to optimize your design control processes in order to reduce waste and increase efficiency. Our approaches help you to shorten development times and make optimum use of resources.
We implement automation solutions that speed up your development processes and minimize the error rate. Automated workflows improve efficiency and ensure compliance with quality standards.
Our training courses and workshops help your team to understand and correctly implement the requirements for design controls and regulatory specifications. This ensures that everyone involved actively contributes to quality assurance in product development.
Ensure the quality of your product development.
Related topics for optimal control of product development.
These supplementary services support you in complying with regulatory requirements and optimizing your development processes:
