Medical Writing Service1. Service Contents1) Design of clinical trial protocols for medical devices/different phases of clinical trial protocols or unconventional study protocols for drugs2) Preparation of clinical protocol attachments (e.g., case report forms medical history, informed c
1. Update, interpretation and counseling of NMPA regulations and policies2. Chinese policies for medical devices, market access, strategic planning and direction, and registration and application strategy3. Analysis on Chinese medical device industry and market segments, CRO investment and financing
Professional TrainingProvide registration-related skill training for personnel, special training on sustainable compliance for enterprises, and customized services.1.Regulatory trainingThis training is provided periodically at different regions.1.Description on medical
Professional Translation ServicesThe Medical Device Translation Platform of the company is dedicated to professional translation of the medical device industry, covering translation of professional technical materials such as pre-marketing regulatory registration process, product testing, tech
Medical MonitoringOur professional medical monitors can help the project team to better understand the objective, inclusion & exclusion criteria and process of the clinical trial, provide medical support for the project team, and ensure that subjects are safe and that clinical trial data are acc
Safety VigilanceTigermed-Jyton is dedicated to advance the process of product marketization through reducing the R&D risks, saving R&D expenditure and providing high-quality clinical trial services.With stable and high-quality team members, Tigermed-Jyton Safety Vigilance and Medical M
Since the National Medical Products Administration imposes increasingly stricter requirements on the clinical study of medical devices, the sponsor, CRO and research center pay more attention to the quality management of the clinical study. The Good Clinical Practice (GCP) for medical devices emphas
1. Scope of data management service• Data management consulting and training• Paper and EDC project• Case report form design• Database creation and test• Making data management plans• Making data review plans• Logic review programming and testing• Double data entry and check• Electronizatio
OverviewClinical Evaluation of Medical Devices refers to that the registration applicant or the filing applicant validates whether the product meets the operating requirements or the scope of application through clinical literature, clinical trial data and clinical trial, etc.In accordance wit
1. Service DescriptionWhen a list of non-conformities is given after the external audit, we can make a corrective action plan based on it.The GMP consulting team of Tigermed-Jyton Group can provide:Customized writing for single processes;Preparation of the system correction plan;Preparation of
