1. Clinical trials of Class II and III medical devices

2. Preclinical research on medical devices

3. Design of clinical trials for medical devices

4. Clinical monitoring of medical devices

5. Medical device data management and biostatistical analysis

6. Compilation of medical device clinical trial reports

7. Application for clinical trial approval (applicable to high-risk products)

1. Clinical trials of class II and III in vitro diagnostic reagents

2. Preclinical research on in vitro diagnostic reagents

3. In vitro diagnostic reagent clinical trial design

4. Clinical monitoring of in vitro diagnostic reagents

5. In vitro diagnostic reagent data management and biostatistical analysis

6. Compilation of clinical trial reports of in vitro diagnostic reagents

1. Compilation of clinical evaluation data for Class II and III medical devices

2. Compilation of clinical evaluation data for class II and III in vitro diagnostic reagents

3. Collection of domestic and foreign clinical literature

In May 2015, NMPA issued the "Technical Guidelines for Clinical Evaluation of Medical Devices". Since then, when applying for registration of Class II and III medical devices in NMPA, if the product is not listed or does not meet the conditions of the "Clinical Trial Exemption Catalog", the There are two ways for pre-market clinical approval: 1. Provide clinical evaluation data, also known as "comparison report of the same variety", "clinical evaluation report", "clinical equivalence evaluation report"; and "authenticity data", etc. Can be used for clinical evaluation; 2. Clinical trials.

The following products are applicable to the clinical equivalence evaluation reporting route:

(1) Localization of imported products;

(2) Failure to renew the registration in time, resulting in products that need to be re-registered;

(3) The product remains unchanged but needs to be replaced due to changes in other information such as the manufacturer;

(4) Existing products on the market, follow-up research and development products of the same company (the company has previous products or similar products on the market);

(5) Products that have been listed on the market and that the same group/enterprise has established factories in different regions;

(6) The enterprise has no previous products or similar products on the market, but can obtain the authorization and technical information of similar products;

(7) The company does not have a previous generation product on the market, but the product's own characteristics, risk level and clinical safety and effectiveness verification method are suitable for the clinical evaluation (CER) approach.

1. Develop and implement a project management plan and a risk management plan

2. Develop and implement a budget management plan for the project

3. Assist clients to quickly complete center screening, investigator selection and patient recruitment

4. Organization and holding of regular investigator meetings

5. In the process of clinical monitoring business, strictly implement the SOP of the customer or the company

6. Case report form verification, original data verification and data query form resolution, etc. All monitoring related work

7. Central screening, startup, routine and shutdown visits

8. Provide serious adverse event reports and related documents to clients and government regulators

9. Keeping and distributing medical records

10. Independent Audit of Medical Device Clinical Trials (GCP)