During the development process, we regularly conduct formal design reviews and thoroughly check the results to ensure that all requirements are being met:
- Are the requirements systematically recorded and quantitatively documented?
- Do the results satisfy the requirements?
- Has the risk analysis been properly performed, and the risk control measures implemented?
- Is the product being developed in a manner which allows future production without problems?
- Is the project documentation complete and in compliance with the standards, regulations, and current technology?
- Is the project on track? Is it on schedule?
- etc.
Design reviews are especially important in the development of medical devices. ISO 13485 requires systematic reviews at suitable stages of design and development to evaluate the ability of the results to meet requirements and to identify and propose necessary actions.
Advantages of konplan
- Competence in design review according to ISO 13485 (Design and Development)
- Experts in medical technology development, and risk management according to ISO 14971
- Highly qualified specialists with deep practical experience from their numerous development projects.
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Developing together! We put your ideas into practice and accompany your projects until they are ready for the market. Get in touch with our experts now.
Additional relevant services
Verification
We are the experts for medical product technology
Validation / Qualification
Compliant and efficient
Software Maintenance
Our holistic view of the product life cycle
Risk Management
Risks always under control
Requirements Engineering
Requirements clearly elaborated
Product creation and design
Attractive and sensible design
Design to Cost
We have the cross-industry, external perspective
