Our understanding of the regulatory differences regarding the conduct of medical device trials enables Clinmark to provide full service of medical device trial conduct, from the protocol design and writing, data monitoring and medical monitoring, to project management and preparation of the final report. Based on broad experience, Clinmark has created a base of potential research sites, particularly in the area of cardio-vascular diseases and cancer diagnostics. The compliance of a study with its endpoints, all the requirements and regulations, including ISO-14155- 2011, is our priority
Clinmark provides a full range of quality and regulatory services, ranging from pre-CE marking clinical investigations and initial device classification to post market surveillance meeting the restrictive requirements of MDR and IVDR
Clinmark is unique, fast growing, Contract Research & Consulting Organization assisting pharmaceutical, biotechnological and medical devices companies in clinical trials planning and execution. We provide full scope of services required for successful clinical development, as well as top level clinical consulting and quality oversight services worldwide. Clinmark team is specialized in compliance, quality, regulatory affairs for the MedTech industry.
As a medical device manufacturer interested in EU market, maintaining regulatory compliance and securing CE Marking for your product is a must, regardless of whether you outsource one or all components of your manufacturing operation. CE Marking indicates that your medical device complies with applicable EU regulations and enables the commercialization of your products across all EU member states.
Clinmark is ready to bring your medical devices to EU market. Clinmark’s team provide all services related to CE marking and registration of medical devices and in vitro diagnostic devices. Our experts have wide experience in the preparation and planning of every stage of the CE Marking Regulatory Process.
- Verification of qualification & classification – Clinmark will support you with evaluation whether the given medical device meet requirements of MDR 2017/745 or IVDR 2017/746, depending on the relevant regulation, we carry out the appropriate medical device qualification and also classification necessary for the selection of the appropriate CE Marking procedure.
- Analysis in accordance with harmonized standards are to ensure that the medical device is effective and safe for use. The risks associated with the products must be identified, assessed and evaluated, and the effectiveness of the risk management process must be monitored, which is described in e.g.: ISO 14971; ISO 10993-1; IEC 60601-1; IEC 62304. Establishing a Quality Management System – The requirements for the Manufacturer’s Quality Management System (QMS) are contained in MDR and IVDR. Additionally, ISO 13485 defines the requirements for a quality management system in which an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and applicable regulations.
- Risk management and analysis – the MDR 2017/745 and IVDR 2017/746 deal with the risk management requirements in great detail. Additionally, ISO 14971 is the global standard for medical device risk management for manufacturers. An in-depth risk analysis helps the manufacturer to develop principles of safety and use of the medical device.
- Clinical Evaluation – conducted based on literature review or on clinical investigation, is the responsibility of every manufacturer of a medical device. It is a continuous procedure, with reliable methodology, to collect, assess and analyze clinical data on the medical device, to verify whether the clinical evidence provided confirms the conformity of the medical device with the essential requirements for safety and efficacy in use in accordance with the instructions provided by the manufacturer. We have many years of experience in medical writing and various analyses, including for medical devices. We can support you with professional preparation and conducting clinical evaluation.
- Preparation and verification of technical documentation – the purpose of developing technical documentation is to ensure compliance with the essential requirements of the medical device. Clinmark will help with preparation or verification of documentation and conducting all pre-clinical tests.