Medical Devices Institute Powered by Excopan Ecosystem
Excopan is a consulting firm with more than 20 years of experience in the medical device industry. Excopan offers comprehensive consultancy services to medical device manufacturers and importers to comply with the medical device regulations in force in Turkey and the European Union.
Ecosystem Company
EXCOPAN's Services:
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Medical Device Legislation Consultancy: Excopan offers up-to-date and comprehensive consultancy services to medical device manufacturers and importers on medical device legislation.
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Conformity Assessment: Excopan carries out the necessary tests and analyzes to evaluate the compliance of medical devices with the legislation in the European Union and Turkey.
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Clinical Trials: Excopan provides consultancy services to companies on the planning, conduct and evaluation of clinical studies of medical devices.
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Education and Information: Excopan organizes various training programs on medical device legislation and quality management systems for those working in the medical device industry.
The consultancy services and academic activities provided by the Institute are made possible by the Excopan Ecosystem.
EXCOPAN's Benefits to the Industry
EXCOPAN provides comprehensive consultancy and support services to companies operating in the Turkish medical device sector, making significant contributions to the development of the sector.
01
Consulting
EXCOPAN supports manufacturers of medical devices and in vitro diagnostic devices in complying with the strict regulations of the European Union, such as MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation). This way, companies can safely place their products on the market and document their compliance with international standards.
02
Quality Management Systems
EXCOPAN provides consultancy to medical device manufacturers on the establishment and integration of international quality management systems such as ISO 13485. This service increases the product quality and reliability of companies, provides a competitive advantage and eliminates question marks regarding compliance with regulations.
03
Education & Awareness Programs
Training and awareness programs organized for employees of companies operating in the medical device sector increase the level of knowledge and skills in the sector. With such training, EXCOPAN ensures that employees are informed about current regulations and best practices.
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Clinical Evaluation & Performance
EXCOPAN provides expert consultancy services in the clinical evaluation and performance testing of medical devices. These services help prove the efficacy and safety of products, facilitating their acceptance in the market.
05
Market Access & Approval Processes
EXCOPAN manages all processes required for medical device manufacturers to obtain approval for their products in the European Union and other international markets. The support provided for the preparation of CE marking and other necessary documents contributes to the growth of companies in the global market.
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Risk Management & Optimizations
EXCOPAN provides consultancy to medical device manufacturers on risk management and process optimization, increasing the efficiency of production processes and minimizing potential risks. These services enable companies to reduce operational costs and increase product quality.
