Quality and regulatory processes for medical production facilities and dialysis centers are not just a requirement, but a fundamental building block for sustainable success and access to international markets. At Hayal Medical, we plan and implement your projects from the outset in full compliance with relevant standards and regulations.
We provide comprehensive support at all stages, from technical documentation to validation processes, from quality management systems to certification preparations. Our goal is to ensure that our clients not only start production but also have a reliable and competitive structure ready for audits.
Thanks to our experience in regulatory processes, we simplify complex requirements and contribute to the timely, smooth, and complete completion of projects.
The CE marking process, which is necessary for placing medical devices on the market, requires detailed technical knowledge and meticulous documentation. We provide guidance throughout this process, from product classification and technical file preparation to testing and conformity assessment stages.
Our aim is to ensure that your products are certified in full compliance with European Union standards, while ensuring that the process proceeds quickly and accurately.
ISO 13485 quality management system is an internationally recognized standard for medical device manufacturers. Within this scope, we establish your company's quality management system from scratch or improve your existing structure.
By providing active support in documentation creation, process definition, internal audit preparation, and certification processes, we ensure that your company has a sustainable quality infrastructure.
Verification of production processes and equipment is critical for ensuring the continuity of product quality. Accordingly, we plan and execute all necessary work such as equipment validation, process validation, and cleaning validation.
In addition, we prepare technical files, standard operating procedures (SOPs), quality guides, and all other necessary documentation in accordance with international requirements. This ensures that your business is audit-ready, transparent, and reliable.