TAILOR-MADE SERVICES FOR THE MEDICAL INDUSTRY
Ilyin Services is a company specialized in regulatory compliance for the medical device and in vitro diagnostic medical device industries. We offer superior services to our customers to support them throughout the process of regulatory compliance of their products.
Discover our services:
At Ilyin Services, we offer a complete service for the implementation of CE Marking files for the medical device and in vitro diagnostic medical device industries. We are committed to providing complete, accurate technical files that comply with current regulatory standards.
We also coordinate with notified bodies to ensure that files are submitted and approved on time. We understand the importance of regulatory compliance to our customers and were are proud to support them throughout the process. We provide you with the necessary skills to help you set up the CE marking files necessary for the marketing of your products on the European market.
At Ilyin Services, we offer a complete international registration service for medical devices and in vitro diagnostic medical devices to various countries around the world, such as the United States, Canada, Switzerland, Mexico, Brazil, etc. We identify the specific regulatory requirements of each country concerned and are committed to providing complete and accurate application files to ensure fast and efficient registration.
We also working to identify potential authorized representative to help our customers meet local requirements. We negotiate quotes and set up contracts to ensure that our customers are represented by reliable and competent partners.
At Ilyin Services, we offer a complete product risk management file preparation service for the medical device and in vitro diagnostic medical device industries in accordance with ISO 14971. We are aware that risk management is a crucial element for regulatory compliance and patient safety, which is why we offer you the management of risk management activities related to your products.
We also write comprehensive risk management documentation to meet regulatory requirements and to help you implement effective and systematic risk management for your products.
At Ilyin Services, we offer services for carrying out normative and regulatory monitoring for the medical device and in vitro diagnostic medical device industries. We are aware of the importance of staying informed of changes in standards and regulations to ensure their safety.
We identify for you the evolutions of the standards and regulations in force in your sector of activity and in the countries where you operate. We also prepare gap-analysis to help you assess the gaps between your current practices and the new regulatory requirements.
At Ilyin Services, we offer regulatory strategy services for the medical device and in vitro diagnostic medical device industries. We understand that the regulatory compliance process can be complex and tedious, which is why we provide you with our expertise in this area to help you identify the different compliance paths and choose the best strategy for your products.
We work with you throughout the regulatory compliance process to ensure the safety and security of your products.
At Ilyin Services, we offer ISO 13485 compliance support for the medical device and in vitro diagnostic medical device industries. We understand the importance of compliance with quality standards to ensure the safety and effectiveness of your products.
This is why we support you in the preparation of the quality documentation necessary to comply with the ISO 13485 standard.
At Ilyin Services, we offer product life cycle management service for the medical device and in vitro diagnostic medical device industries. We understand the importance of maintaining regulatory compliance and the quality of your products throughout their life cycle. We offer you follow-up in the management of changes and obsolescence of your products, ensuring that changes are made in accordance with current regulatory requirements.
We also help ensure that product changes are well documented, and that relevant information is communicated to relevant stakeholders.
At Ilyin Services, we offer post-market surveillance services for the medical device and in vitro diagnostic medical device industries. We understand the importance of continuously monitoring of the safety and performance of your products once they are on the market. We will help you create PMS plans and reports adapted to your needs and products, taking into account current regulatory requirements.
We can also help you identify adverse events associated with the use of your products and determine appropriate corrective measures to maintain the safety and performance of your products. Our goal is to help you ensure the continuous safety and performance of your products after they are placed on the market.