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?
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.