*As of Q1 2020
As the largest MD and IVD regulatory and clinical trial CRO service provider in China, Tigermed and its over 300 full time experienced medical device clinical research professionals, have established long-term cooperative relationships with over 1400 manufacturers from more than 30 countries throughout the last 20 years. We assist your activities in Medical Device/In Vitro Diagnostic development and manufacturing process, to cope with the ever changing regulatory requirements globally.
*As of Q1 2020
- 4900+ regulatory projects
- 300+ clinical trials
- 1400+ clients
*As of Q1 2020
- Dedicated to medical devices: The first CRO company dedicated to medical devices in China, having 20 years of relevant experience.
- SOP strictly complying with NMPA regulations, efficient communication mechanism and internal quality control & supervision mechanism.
- Experience of 5,000+ projects covering all subdivisions of medical devices, with 300+ registration certificates obtained each year.
- Full lifecycle services: one-stop services from pre-market products R&D to post-marketing support.
- Leading the medical device industry in China with successful experience of innovative, high-risk, long-term implantation, and cutting-edge products.
- Reliable choice based on participating the amendment of industrial standards and guidelines for medical devices.
- Professional service team consisting of more than 300 full time employees in the field, with 10+ years experiences in supervisor level.
- Long-term and reliable cooperative relationships with many well-known medical device enterprises in the world.
- Medical Device Testing
- Regulatory Submission
- Clinical Evaluation
- Clinical Trials
- GMP Certificate
- EU MDR & IVDR Preparation
- Value Added Services
Medical Device Testing
Biological Evaluation & Entrusted Testing
For Medical Devices intended to be used in the human body, firstly, qualitative analysis on the material used and analysis on existing data or relevant information should be performed. Then, a simulated in vitro biological test and an in vivo animal test should be performed as needed. Based on comprehensive information, data analysis and/or safety test assessment, a relatively scientific assessment and risk evaluation is finally made for the medical device regarding use in the human body.
Entrusted test can be resorted to when the purpose cannot be realized by self-test, or the self-test means are limited. The entrusted testing institution should have corresponding testing capability. With respect to NMPA registration, the entrusted test can be considered as the pre-test of registration test at present. As a part of the biological evaluation, the biocompatibility test belongs to the entrusted test.
For every product you wish to market, it’s imperative to plan your submission carefully, and to keep tracking of each milestone and possible hurdle that you might come across. Planning and a well-developed strategy are key to this process and knowledge of different regional Health Authorities can mean the difference between failure and success.
Commercializing your medical device or IVD requires various registration strategies. Thanks to our global presence and experience, we can assist you for success to commercialize your Medical Device or In Vitro Diagnostic and for interaction during the submission process with regulatory authorities such as US FDA, EU Notified Bodies, and China NMPA, etc..
- Product Category/Attribute Confirmation
- Innovation Channel Application
- Registration/Filing Application
- Overseas Registration
- Legal Agent Service
- Regulatory Consultation
Clinical Evaluation of Medical Devices refers to that the registration applicant or the filing applicant validates whether the product meets the operating requirements or the intended use through clinical literature, clinical practice data and clinical trials, etc.
It involves the assessment and analysis of clinical data related to your Medical Device to demonstrate its clinical safety and performance. A high-quality clinical evaluation report is an important aspect to keep in mind when pursuing market authorization and/or CE certification.
Depending on the risk classification of your Medical Device, you may or may not be required to provide Health Authorities with clinical evidence to be able to commercialize your product. As a CRO offering one-stop solutions for Medical Device development globally, Tigermed is optimally suited to assist you with clinical trial management.
- Medical Writing
- Clinical Monitoring
- Quality Control
- Clinical Operation
- Safety Vigilance
- Medical Monitoring
- Medical Device Biometrics
In vitro diagnostics products vary greatly from regular medical devices and often involve the application of associated instruments. Additionally, there are significant differences between China, the US, and Europe regarding classification and registration of in vitro diagnostics product. In clinical trials of in vitro diagnostics products, samples are often collected for testing in a centralized manner thus increase the speed at which the enrollment and testing is performed. The proper handling of sample storage, and the proper use of reagents and the associated instrument are also very important for the test results.
- IVD Research and Development
- IVD Regulatory Submission
- IVD Clinical Trial
Requirements for the manufacturing and the distribution of medical devices are laid down in various guidelines and standards across various regions. In the US, Medical Devices are regulated by the FDA in their cGMP regulations for Medical Devices (21 CFR 820, QSR), in Europe, three EU directives (90/385/EWG, 93/42/ EWG and 98/79/EG) and one amending directives (and soon the new Medical Device Regulation will publish), and in China, the authorities are driving GMP standards to be more closely aligned to International Organization for Standardization (ISO) standards to stimulate its medical device market. Tigermed is uniquely positioned to support you in this area in all the three regions.
- Correction Counseling
- Clean Room Counseling
- Operation Counseling
- GMP System Establishment
- Production License
EU MDR & IVDR Preparation
Implementation of the MDR or the IVDR is an extensive project and the road to it is paved with challenges. Putting it shortly, all companies are strongly advised to come up with a comprehensive transition plan. To ensure continuous compliance of your products to the new legislation, an early start, a thought-through plan, and management buy-in are necessary elements to a successful project.
- Mapping relevant differences
- Risk Classification
- Conformity Assessment Procedure
- Implementation Plan
- Product Documentation
- Quality Management System
- Post Market Activities and Reporting
Value Added Services
Our experts understand very well that there is no one-size fits all solutions for Medical Device products which is why Tigermed also offers several diverse Value-Added Services. We can provide you with consultants with expertise in any of the above-mentioned roles and responsibilities or train your own staff.
We offer tailor-made solutions to benefit both small-scale startups and well-established corporates, and above all we understand how to balance different needs within Medical Device companies and to combine compliance with business success.
- Professional Translation Services
- Professional Training
- Consulting Service
- Third Party Audit
The new EU MDR has stringent rules regarding clinical evidence. Make sure your product is allowed to stay on the market by generating your clinical data as soon as possible.
Contact us to find out if your medical app or software is actually classified as a Medical Device and start the road to compliance.