What kind of cooperation is needed for the mass production of laparoscopic trocars ?

1. Technical requirements and product specifications: the products are confirmed by the commissioning party and meet the requirements of relevant local technical specifications. The product model, specification and its division description are clear, including the size and function of the puncture trocar and puncture cone.

2. Production qualification and compliance: Donho distinguishes the requirements according to the form of commissioned production. At the same time, it is necessary to provide a valid quality management system certification, such as ISO13485 certification.

3. Biocompatibility and Sterilization Requirements: The materials used for the applicators must be biocompatible to ensure that they do not cause toxicity or allergic reactions to the human body. The products need to be sterilized before use. Considering the breakdown of job responsibilities of the commissioned production, specific communication can be carried out.

4. Mechanical properties: the device needs to be strong and stable enough to withstand a certain amount of pressure during puncture without breaking. Mechanical performance testing includes determining the strength and stability of the puncture device under specific conditions.

5. Production environment and equipment: The production environment should meet the environmental requirements and have clean and tidy workshops and equipment. Employees should receive relevant training to ensure the health and safety of employees.

6. Quality control process: There are detailed quality management system and process, regular inspection and sampling of raw materials and semi-finished products to ensure compliance with quality standards. Establish a reasonable quality file and traceability system, as well as a risk management system.

7. Design verification and process verification: In the product design stage, design verification is carried out to ensure that the product functions and performance meet the expected requirements. During the production process, process validation is carried out to ensure that the whole process can stably produce products that meet quality standards. Flexible adjustments are made according to the results of communication between the commissioner and the commissioned party.

8. Automated assembly technology: In order to improve production efficiency and reduce costs, Donho adopts automated assembly technology. The automated assembly machine can automatically complete the gripping, transferring, positioning and assembling of parts, reducing human error and improving product quality and production efficiency.

9. Clinical data and test reports: During the product registration process in each country, customers can submit complete technical documents to the local organization, including product design description, test reports, clinical data (if any), etc.. The clinical test report describes in detail the design, execution, data collection, statistical analysis and interpretation of results of the clinical trial.

10. Supply chain management: In terms of supply chain management, there is a need to ensure the stability and quality of raw material supply to support the demand for batch production. Effective supply chain management can reduce costs, improve service quality, and achieve efficient operation of the medical device supply chain.

The above conditions together ensure that the batch production of disposable laparoscopic trocars can achieve high efficiency and stability under the premise of guaranteeing product quality and safety.Donho can accept global cooperative commissions for commissioned contract production and delivery of zero components, which can effectively reduce the overall investment and shorten the cycle from development to batch production.