Injection molding services for medical parts are an important part of modern medicine. With the continuous development of injection molding technology, medical devices have also been rapidly developed and popularized.
The advantages of injection molding technology for medical parts are reflected in its high production efficiency, low cost, and reliable quality. Due to the extremely high quality requirements of medical devices, the medical parts injection molding industry pays attention to quality monitoring during the manufacturing process to ensure the stability and consistency of the products. At the same time, the materials used in the injection molding of medical parts during the production process are certified to ensure the safety and hygiene of medical devices.
Plastic injection molding companies provide products and services to a variety of customers. The products usually required by the medical industry are medical devices. Unlike standard plastic injection molding processes, medical plastic injection molding exceeds the standards. This plastic injection molding service not only involves plastic materials, molds, and suitable machines, but also needs to meet the standards set by the industry.
Because in the field of medical device manufacturing, stable quality is the most important consideration. Medical parts injection molding technology can ensure the excellence of every detail of the product and ensure that no quality defects will occur during the production process. At the same time, this technology also uses advanced production equipment and processes to produce and process medical accessories with high efficiency and quality, which helps to improve patients’ treatment effects and the experience of the medical process.
Elimold injection molding service helps medical device precision manufacturing
Elimold focuses on providing product samples, small batch plastic and metal processing, and one-stop customized processing services for customers in the medical device manufacturing industry. We provide cost-effective processing services for plastic appearance parts, structural parts, and metal structural parts of medical products.
In addition to providing medical injection molding services, we can also use 3D printing, CNC Machining and other technologies to produce high-precision, complex structural models and equipment parts for treatment, medical research, education, and surgical planning. Moreover, the models we manufacture can accurately reproduce the vascular and neural structures of some organs, providing medical workers with advanced equipment and detailed physical models for analysis and research.
At the same time, we also provide medical product rapid prototyping services to ensure the effectiveness of product design and the feasibility of production. Medical product prototyping uses a complex verification process of multiple materials and multiple advanced manufacturing technologies at the same time. Therefore, the processes we provide can be selected, involving SLA stereolithography printing, CNC machining, spraying, grinding, spraying and assembly. The choice of process depends on factors such as the complexity of the prototype, precision requirements, and production cycle.
Elimold can also provide processes such as low-pressure infusion (RIM), compound molding, and vacuum thermoforming (RTM), which can quickly and cost-effectively produce product samples or small batches of products without investing in large-scale production equipment, helping companies verify the feasibility of the design and market acceptance. At the same time, it can test various parameters in the production process to identify potential problems and optimize the design.
Elimold Medical Device Precision Manufacturing Industry Standards
Injection molding of medical parts is a widely used production method in the medical industry. It has the advantages of high precision, low cost and high production efficiency, so it is widely adopted. However, before using this production method, it is necessary to ensure that the medical parts produced meet the highest quality standards and specifications. Elimold can meet the following standards related to medical device injection molding.
FDA Requirements
For medical component manufacturing, FDA requirements are the target standard in all processes. The regulations for sterility and cleanliness are very strict and need to be strictly followed. At all stages of production, ensure that all inputs meet or exceed the specified standards. For medical-grade certification, the factory must pass the standards in both the components and the production process.
Durable and reliable medical-grade components that meet FDA standards can be produced through medical injection molding. This process is now the preferred procedure for manufacturing the most advanced medical devices because it provides countless advantages.
ISO Standards
ISO standards are both general, such as ISO 9001, which indicates that your organization meets certain basic principles related to quality management, and specific, such as ISO 13485, which indicates that a manufacturing cleanroom meets certain responsibilities and performance requirements. ISO alone does not ensure that manufacturers meet its requirements. It is the job of ISO officials to set the standards; other certification bodies and companies around the world are responsible for conducting audits to determine whether facilities actually meet or exceed those standards. In the United States, a small number of certification bodies oversee the standards and provide certification.
ISO 9001:2008 Certification
ISO 9001 certification essentially tells your facility that it is very clear about how to maintain quality standards and is continually seeking to improve the level of quality in the parts manufacturing process. Facilities that are ISO 9001 certified maintain detailed documentation of any procedures used to operate effectively. Specifically, each facility is required to maintain detailed records in six areas: Document Control (4.2.3), Record Control (4.2.4), Internal Audit (8.2.2), Control of Nonconforming Products/Services (8.3), Corrective Action (8.5.2), Preventive Action (8.5.3).
Companies that are ISO 9001 certified are also required to maintain a written quality policy and quality manual that includes documented operating procedures.
ISO 9001 certification is not a “set it and forget it” thing; companies must renew their certificates every three years. Certification standards are also regularly developed to reflect new technologies and methods for maintaining quality within an organization. There are more detailed ISO certifications for specific industries, such as computer software, oil and gas, and medical devices.
ISO 13485:2022 Certification
ISO13485 is a management system standard specifically for the medical device manufacturing industry that provides specifications for ensuring the quality and safety of medical devices. The standard requires manufacturers to manage and implement comprehensive supervision and control of their production processes to ensure that the medical products they produce always comply with the medical regulations and quality standards of all countries and regions. Therefore, medical accessory manufacturers need to follow the ISO13485 standard to ensure that their production processes are standardized and regulated, and ultimately produce high-quality, safe and reliable medical accessories.
ISO 13485 certification can ensure that their parts are manufactured in a cleanroom environment, which is required by many medical device manufacturers in Europe, Canada, Australia and Japan. The certification requirements are similar to the Food and Drug Administration’s current good manufacturing practices (CGMP). ISO 13485 has many similar quality requirements to ISO 9001, but with a special focus on keeping the environment clean. Certification does not rely on any customer satisfaction feedback, such as ISO 9001, but facilities must prove that they have effectively implemented and maintained the quality system necessary to ensure that the cleanroom remains clean.
When producing medical devices, it is imperative to ensure that the conditions, environment, molds, molding equipment, and materials meet and comply with ISO quality systems. In order to meet and exceed these standards, companies that provide plastic injection molding services must have highly controlled product systems that record arrival times and shipment times. For example, ISO-13485 states that if your equipment or control systems do not meet ISO standards for medical devices, the materials produced will not be usable. Therefore, in order for a company to provide this high-quality medical plastic injection molding, it must renew its certifications annually to meet certain ISO standards.
Our medical parts injection molding follows the following ISO13485 standards:
- Production process control: In medical parts injection molding, strict control of the production process is required to ensure that each link of the production process is strictly in accordance with the established specifications to ensure product quality and production efficiency.
- Traceability and tracking: In order to ensure product quality, manufacturers need to trace and track their production processes. This allows abnormal events and failures to be traced and found, so that the manufacturing process can be adjusted and corrected to ensure that the product meets the specified quality standards.
- Manufacturing process and process control: Medical parts manufacturers must set manufacturing processes and processes during the injection molding process and adopt management methods that comply with ISO13485 standards. This allows the normalization and standardization of the production process and ensures that the final medical parts produced meet the specified quality standards.
- Quality management: In medical parts injection molding, comprehensive quality management must be achieved. Manufacturers should formulate quality management procedures that comply with ISO13485 standards and strictly implement them to ensure that the medical parts produced meet the specified quality standards and their quality is inspected and tested.
Medical clean room injection molding workshop
The injection molding process of medical accessories needs to be carried out in a clean production environment, so manufacturers that can provide medical device injection molding services usually have clean rooms that meet the standards. Because medical clean rooms are a necessary condition to ensure the quality and hygiene standards of medical accessories injection molding production. Medical clean rooms usually refer to manufacturing processes that design and configure clean rooms, clean equipment and corresponding air purification devices according to a certain environmental cleanliness to achieve a certain degree of cleanliness.
Therefore, medical clean rooms must comply with the specifications and standards of the medical industry. According to industry standards and medical industry standards, medical clean rooms need to be divided into different levels, which are suitable for different medical accessories injection molding process applications. In medical clean rooms, production equipment, testing equipment, air filtration systems, anti-static systems and other facilities need to be set up to ensure the cleanliness, stability and efficiency of the production process.
In addition, medical accessories injection molding manufacturers must have the ability to systematically manage and maintain medical clean rooms. Because medical clean rooms are complex systems that require regular inspection, maintenance and cleaning to ensure normal operation and maintenance of cleanliness. Medical parts injection molding manufacturers must establish a sound management system, formulate relevant operating procedures and management systems, strengthen personnel training and skills improvement, and ensure the standardization and effectiveness of the management and maintenance of medical clean rooms.
Medical parts injection molding manufacturers need to continuously improve the technical level and equipment level of medical clean rooms, as well as the continuous upgrading and improvement of the technology and equipment of medical clean rooms, in order to better support the injection molding production of medical parts. This requires medical parts injection molding manufacturers to keep up with the development of cutting-edge technologies in the industry, improve their own technical capabilities and production efficiency, in order to promote the entire medical parts injection molding industry to develop in the direction of higher quality and higher efficiency.
Biocompatibility testing
Medical accessories usually need to undergo biocompatibility testing to ensure their safety for the human body. These tests usually include in vitro testing and in vivo testing. In vitro testing generally uses biological reagents, cell culture and other methods to directly test medical accessories. In vivo testing requires that medical accessories be directly implanted into experimental animals or humans to observe their reactions and physiological effects. These tests can test and evaluate the materials, shapes, drug release and other aspects of medical accessories. Therefore, injection molding manufacturers with biocompatibility testing are fully capable of producing most medical devices.
Injection Precision Mold Manufacturing and Maintenance
There is an inseparable relationship between the quality of medical accessories and medical precision molds. The precision molds used in the manufacturing process of medical accessories have an important impact on the accuracy, quality and reliability of the medical accessories produced. The manufacturing and maintenance of precision molds are crucial to the success of medical accessory manufacturing. Medical accessory manufacturers need to select high-quality medical precision molds to ensure the high quality, accuracy and reliability of medical accessories. At the same time, in the process of precision mold production and maintenance, high technical skills and rigorous operating specifications are required to ensure that every medical accessory produced meets the highest industrial standards and quality requirements.
In the medical field, precision molds play a vital role in the manufacturing process for the production of high-quality and reliable medical accessories. Therefore, medical accessory manufacturers and precision mold manufacturers must work closely and follow the highest industry standards and safety requirements to meet the needs of patients and provide them with the best quality medical care. Generally speaking, manufacturers that can manufacture medical device parts are generally able to manufacture and maintain relevant injection molds.
Correctly choose an injection molding integrity OEM service provider
When you need to choose a suitable medical plastic injection molding company, the most basic threshold is to choose a company that meets industry standards. In the field of medical injection molding manufacturing, many injection molding manufacturers have become industry leaders. They have advanced technical equipment and technical advantages to produce high-quality medical accessories and devices. Medical accessories injection molding manufacturers not only need to have rich production experience, but also need to continue to invest in research and development to improve the quality and technical level of products. This includes Elimold.
A good medical accessories injection molding manufacturer will maintain a close cooperative relationship with medical device manufacturers, understand customer needs, and customize production according to needs. In the process of cooperation with customers, medical accessories injection molding manufacturers need to continuously improve their own technology and production capabilities to meet customers’ ever-increasing quality requirements and market competition challenges.
Because medical device companies often propose medical device designs that cannot be molded or cannot be manufactured through injection molding services. As medical device designs become more and more sophisticated, the physical and material limitations of injection molding these parts will also increase. In this case, the ability of the injection molding manufacturer will be greatly tested. A good mold manufacturer can usually help customers redesign the parts, which also includes reliable communication skills and a common understanding of the required materials and part design.
Conclusion
As a high-precision manufacturing technology, medical device injection molding has broad application prospects in the production of syringes, catheters, medical device housings, surgical instruments and laboratory supplies through its high precision, high quality, high efficiency, diversity and repeatability. With the continuous advancement of medical equipment and related technologies and the expansion of applications, medical device injection molding will continue to play an important role in improving manufacturing accuracy, optimizing product quality and reducing production costs. It is hoped that the medical device industry can make full use of this high-precision manufacturing technology to achieve higher production efficiency and product quality, and promote the development and progress of the medical device industry. If you need medical device injection molding services, you can contact Elimold to serve you.