CDMO services - 清泽医疗

CDMO services Full chain professional technical services for medical devices

1: Site planning
2: Entrusted R & D
3: Marketing
IV: Product approval

CDMO Service 1: Site Planning

According to factors such as the medium-and long-term strategic plan, industrial policy, business environment, product process, and production model of the medical device registrant, provide forward-looking, systematic and scientific guidance and review on the site selection of self-built factories, site selection of leased factories, clean factories/workshops/laboratories design, and clean factories/workshops/laboratories construction to avoid design flaws in factory facilities and eliminate the risk of potential failure in infrastructure construction.

Design, planning, construction and other services for medical clean workshops
Design, planning, construction and other services of medical clean laboratories

CDMO Service 2: Entrusted R & D

Development of biomedical materials

● Medical beauty recycled materials ● Wound repair materials ● Oral restoration materials ● Bone repair materials ● Drug sustained release materials ...... Bio-materials are materials used to diagnose, treat, repair or replace damaged tissues, organs or enhance their functions.
biocompatibility evaluation

● Cytotoxicity test GB/T 16886.5-2017 ● Sensitization test GB/T 16886.10-2017 ● Irritation test GB/T 16886.10-2017 ● Drug sustained release materials GB/T 16886.10-2022 ...... Biological evaluation of medical devices refers to the test items of materials that simulate the use of medical devices under extreme circumstances. The response generated by specific parts of the body is a comprehensive analysis and evaluation that must be tested before being launched.
disease animal model

● Various animal models for wound repair and reconstruction ● Animal models of bone implantation and bone filling ...... Disease animal models refer to animal experimental objects and related experimental materials established during the biomedical research process with simulated manifestations of human diseases, and are needed before clinical trials of products.

CDMO Service 3: Marketing

Policy background

Timely interpretation of the country's changed policies and accurately grasp the industry trend
industry policies

Provide guidance on market access such as charging policies in various provinces and connecting online policies in various places
Bidding guidance

Control the entire process of national procurement, alliance procurement, provincial procurement, municipal procurement, and hospital bidding and guidance on response strategies
Marketing network

Consulting on building marketing network after medical consumables products obtain registration certificates

CDMO Service 4: Product approval

The medical device application process includes product research and development, data preparation, application submission, review and approval, registration and certification, and involves multiple departments and institutions. Enterprises need to formulate R & D plans in accordance with relevant laws and regulations, prepare complete materials to ensure authenticity and accuracy, and actively cooperate with the review department. After completing the process, companies can obtain medical device registration certificates and market them for sale.