Regulatory Strategies
and Safety
Safety Assessment of Medical Devices

TriApex provides our clients medical device services, including development strategies, methodological development and validation, pre-clinical safety assessment, regulatory affairs and quality consultation, and medical writing. TriApex, dedicated to shortening the R&D time, reducing the R&D costs, protecting intellectual property, and promoting successful registration and market approval for our clients, is a high-quality partner of medical device innovation and clinical training.

Service Advantages

As a member of TriApex, Shanghai Harborside Medical Technology Co., LTD. (Harborside) is the US FDA GLP-compliant non-clinical animal laboratory. As the high standard and first AAALAC-accredited (International Laboratory Animal Assessment and Accreditation Commission) third-party institution for pre-clinical assessment in the domestic medical device industry. Harborside is accredited with the domestic and international submission quality system and relevant qualifications. Several pre-clinical safety and efficacy studies have been inspected by FDA PMA/510K and NMPA.

Service Capacities

TriApex provides the pre-clinical safety assessment of medical devices and helps our clients to find and eliminate the blind spots and difficulties of medical device testing, lower the uncertainty, and accelerate the process of product commercialization. Our services involve five modules:

1.Development Strategies of Products

Providing a comprehensive consideration of the proof-of-concept and feasibility studies during product design and development, lowering the risks during product development, and preventing unexpected obstacles during the inspection and inspection testing. We provide services in

Identifying the client requirements, market analysis and competition evaluation

Formulating concepts, plans, timetables and models

Preliminary risk evaluation

Non-GLP function or efficacy studies

Preliminary regulatory, clinical and medical compensation evaluation and strategies

2. Methodological Development and Validation

Harborside is a leading domestic CRO that is dedicated to the R&D tests and pre-clinical studies, and helps you to obtain the most scientific and compliant results in the design validation and pre-clinical test phase of medical device development.

The product design phase is determined during the product development, such as performance and safety parameters. In this phase, we may also conduct confirmatory tests on the selected materials and techniques, including but not limited to:

Updating of registration, regulation strategies and competition evaluation

Clinical requirement confirmation and validation test

Establishment of R&D and production quality system (handbooks and SOPs)

Failure Mode and Effect Analysis (FMEA)

Pre-clinical research strategies and plans

Development and establishment of surgical or disease models

3.Pre-clinical Research Services

TriApex can help medical device manufacturers to test and verify the performance according to the intended function of the product. As the most important parts of pre-clinical studies, systematic safety studies and efficacy are used to select prototypes and understand device performance in specific applications. Our technicians can provide a variety of in vivo models and analytical instruments to provide data support for specific application domains and scenarios of medical devices. Our experience covers the following areas and device types:

Cardiac, Nerve and Peripheral Vascular Plant Interventional Devices

Stent, balloon-expandable stent, suction catheter, valve, medical coil, intravascular ultrasound diagnose and treatment, brain computer interface, AI), cardiac electrophysiology equipment and consumable (Ascension3D GuidancemedSAFE, radio frequency, microwave, frozen, pulsed field ablation), tumor interventional embolization product, and portasystemic shunt, etc.

Devices and Consumables for Surgery and Ophthalmology Operations

Active energy equipment, consumables and devices for minimally invasive surgery, endoscopy and endoscopic devices, hernia and dural graft implant, hemostatic materials, biological dressings, surgical robot systems (soft tissue, vascular intervention, neurosurgery, orthopedics, lung navigation, puncture, etc.), artificial cornea and aqueous drainage devices, etc.

Orthopedics and sports medicine

Screw-plate fixation system made by new material, joint balloon-expandable stent, spinal implantation, artificial ligament, bone repair material, navigation robot system

Drug-device combination products

Customized supports and suggestions for each client.

4.Regulatory Affairs and Quality Consultation

Since medical device companies require global regulatory strategies while pursuing product commercialization, we can provide strategic guidance at each stage of the product development.

5.Medical Writing

TriApex can provide professional report writing services for medical device manufacturers. Clinical experts and scientists with master degree or above in the related fields are engaged to write some or all the study reports used for certification submissions and academic journals. Our report writers work with clinical and management teams to organize, interpret and present data in accurate and professional manners.

Common reports and writings:

Instant and final clinical assessment reports

Cooperation in manuscript for academic journals

Reference summary

Reviewing and editing

Regulatory certification documents

PPT for the ad hoc group