August 6│ Dr. Paul Liu, General Manager of Harborside, will give a webinar on the CMDHRA platform


At the invitation of China Association for Medical Devices Industry Human Resource Association (CMDHRA), Dr. Paul Liu, General Manager of Harborside (Tripod Group), will give a lecture on themes of medical device pre-clinical evaluations and studies on August 6.

 

Main content of this course:

Testing and verification of medical devices, including bench performance testing and animal tests, are important evaluation method throughout the product development cycle, from the determination of early concept, customer requirements and design & manufacturing specifications to the verification/qualification prior to the final marketing release(or clinical trial permission); high-quality animal study helps device manufacturer to identify potential risks early and make modifications and improvements timely at the feasibility study stage, and enable manufacturer to make its products closer to the requirements of the applicable guidelines issued by regulatory authorities at the verification stage for registration submission. Moreover, the truthful, reliable and traceable test data and results (in line with data integrity requirements) from high-quality animal studies also lower the manufacturer’s exposure to subsequent risks.

 

 

Company Profile

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Shanghai Harborside Medical Technology Co., Ltd. (Harborside) is located at Building 6, 19 Zhenglang Rd, Lingang New District,

Shanghai Free Trade Zone, China 201413 . Its predecessor, NAMSA Shanghai Lab, was an FDA GLP-compliant laboratory for pre-clinical animal studies of medical devices. Harborside is the first AAALAC-accredited specific medical device CRO in China.

Harborside has been providing services to many renowned Chinese and foreign companies, including verification testing of products at development stage, experimental study of products at registration submission stage, and training on therapy with post-marketing products, etc. Many pre-clinical studies at Harborside have been approved for FDA PMA/510K, CE and NMPA submissions.

 

Reliable pre-clinical study and innovative experiment team

All members of Harborside’s research team have participated in the pre-clinical studies of numerous products and gained rich experience in protocol development, project execution  and management.

Harborside’s QA team consists of Registered Quality Assurance Professionals in Good Laboratory Practice (RQAP-GLP) accredited by Society of Quality Assurance (SQA); they are CNAS (ISO17025) internal auditors who have experience in NMPA, FDA and OECD GLP laboratory inspections and system establishment.

All experiment personnel are qualified veterinarians who have rich practical experience in animal studies and qualification certificates such as animal study operator certificate and operational radiation safety certificate.

The IACUC consists of the chairman, veterinarians, researchers, non-researchers and external members(s), who are actively engaging animal welfare and ethics.

All facility operators have rich experience in maintenance of GLP laboratories; all facilities meet the requirements of applicable national standards and the company’s quality management system, and support daily studies with high efficiency.

 

Harborside's surgical team

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Harborside’s expansion of the Phase II laboratory and animal facilities had been completed in June, 2022. Presently Harborside has 3 hybrid catheterization rooms, 1 CT room, 4 integrated surgical operation rooms, 15 large animal housing facilities and 6 small animal housing facilities for accommodating more than 20 studies simultaneously; Harborside also has a series of high-end medical equipment for meeting the requirements for verification testings and clinical trainings.

High-end Visualization equipment

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