Services
Medical Device R&D & Engineering
- Device architecture design,
- Development of sensor and measurement systems,
- Electronic and embedded systems design,
- Prototype production
- Verfication and validation tests
ÇORUH Technology Investments and Medical Services provides technical support to companies during the engineering, prototyping, and validation phases of medical device development. Our services:
The goal of these processes is to ensure that the product is ready for the market from both a technical and regulatory standpoint.
Regulation Strategy
- MDR (Medical Device Regulation) compliance strategy,
- ISO 13485 QMS,
- IEC 62304 software lifecycle management,
- Preparation of technical file
- Risk management (ISO 14971)
Regulatory management in the medical device industry is a critical component of the product development process. We provide support to companies in the following areas:
Digital RegTech Solution
- Requirements,
- Risk Analysis,
- Verification Tests,
- Post-Market Surveillance (PMS),
Regulatory processes typically involve a large number of documents, tests, and validation procedures. Managing these processes manually can lead to both time wasted and traceability issues. With a RegTech approach:
can be managed through a single digital platform. This approach offers significant advantages, particularly in complex medical device projects.
Clinical Engineering Applications
- Consulting services for planning the medical equipment and furnishings needs of healthcare facilities based on preliminary designs and feasibility studies,
- Consulting services for the preparation of requirement lists, technical specifications, method statements, and quality manuals for medical equipment and furnishings,
- Consulting services regarding clinical services, equipment layout, and infrastructure in healthcare facilities,