ISO 13485 is a globally recognized standard that outlines the requirements for a quality management system (QMS) for medical device manufacturers. This standard is particularly important in plastic manufacturing processes used to make medical devices, as it ensures that the products are safe, reliable, and effective.
Plastic manufacturing processes involve the use of various polymers and additives to create the desired product properties. In medical device manufacturing, it is crucial to use materials that meet the specific biocompatibility requirements, as well as to maintain strict quality control standards throughout the production process.
The ISO 13485 standard requires medical device manufacturers to implement a QMS that ensures the consistent production of safe and effective products. This includes the use of proper manufacturing techniques, documentation, testing, and quality control procedures. By adhering to these standards, manufacturers can provide medical devices that meet the needs of healthcare professionals and patients while ensuring compliance with regulatory requirements.
At THY Precision, we specialize in plastic manufacturing processes for medical devices and are committed to maintaining the highest standards of quality and safety. Our ISO 13485 certification ensures that our customers can trust us to provide them with reliable and effective medical devices that meet their specific needs.
In conclusion, ISO 13485 is a critical standard for medical device manufacturers, particularly in plastic manufacturing processes. It ensures that the products produced are safe, reliable, and effective, while also maintaining strict quality control standards throughout the production process. At THY Precision, we are dedicated to providing our customers with high-quality medical devices that meet regulatory requirements and exceed their expectations.
At THY Precision, our employees are part of the most valuable assets at our company as they are professional, creative, innovative and highly skilled with knowledge. In order to help our customers to produce precision plastic injection components, they have to get their job done patiently, carefully and hardly. Their contribution and dedication is highly appreciated! If you would like to know more about the products and services we offer, please feel free to contact us. Thank you!
In near future, THY Precision will expand the factory and occupy more production lines for larger production capacity. We expect to satisfy more customers' needs.
After the expansion, THY Precision will be able to provide more production lines for medical consumables. We are committing to provide our customers more professional and efficient solutions on micro molding and tooling.
Thanks for your support in the past. We are looking forward to providing our services with new factory and more facilities.
Due to the Chinese New Year Holiday, THY Precision company will be closed through Jan 29 to Feb 6.
Our office will open on Feb 7, We are sorry for any inconvenience caused. If you have any queries, you can still contact us by email.
We hereby send our best wishes for your whole new year.
Happy Chinese New Year, and may you have the best year in 2022!
Micro molding is a kind of tooling design, it manufactures micro-sized and precision plastic components. This technique can be widely used in medical, electronic, optic, automotive and other different industries. The features of micro part requires minimized tolerance and high consistency. THY Precision, as a professional manufacturer of micro molding and tooling, we can provide customized micro plastic components. From sampling, tooling design, molding to mass production, we are confident to reach customers requirements exactly.
In designing stage, THY Precision utilize the newest and most advanced Moldex 3D software to achieve the highest quality and most efficient results. Engineers use Modex 3D simulation to verify their designs and prevent any potential short shots or tolerance errors before manufacturing. With the simulation, we can save time from trial-and-error. For the quality control, we follow strict protocols and procedures at all stages of production, have temperature and humidity control in production lines. Also, We are certificated by ISO 9001 and ISO 13485. We also inspect our products with the latest and most precision equipments.
With those strict procedures, THY Precision will be your best partner of plastic micro injection molding. Please Contact us if you are looking for a professional micro moulding manufacturer. It will be our pleasure to get your inquiries.
Micro injection molding is a specialist process, and medical device and drug delivery device OEMs that are looking for a micro molding partner must select carefully. THY Precision can provide a complete solution for precision component design and micro mold manufacturing. In medical application, our micro molding process can manufacture components of surgical devices, electronic components for medical devices, Pharmaceutical applications including drug delivery devices, vials, caps, specimen cups... etc. Also, our ability to meet customer requirements and our focus on quality and defect-free parts have made us a good supplier of micro injection molded medical parts. we work closely with our customers to meet their application requirements including: auditing to ISO 13485 medical, clean-room molding, and automated parts assembly and packaging requirements.
With more than ten years experience, THY Precision surely can provide the best, profession services and solutions. We specialize in design and manufacturing precision plastic parts. Contact Us for further inquiries, we will be glad to provide our services.
Micro Molding — Precision Plastic Solution
Micro injection molding is a very special art form, which is a kind of tooling design , manufactures small and precision plastic components. THY Precision as a professional micro injection molding company, we are able to exert the feature of precision plastic molding and make mini-sized plastic components with 1 µm tolerance that can be called an art form. The tiny-scale molding form of injection molding that entails building a cavity to match the shape of the part you want to make. With this feature of flexibility, THY Precision can provide customized services and help our customers design the shape of micro components and molds.
Since plastic is a material that is easier to get, and it is light, shapable, we commonly use plastic products and components. Precision plastic injection molding technique is an extreme example for applying plastic material. It is obvious that we are pursuing the same thing in different fields like medical, optical, automotive and electronic — lighter, smaller and more precision. We THY Precision specialize in provide you the best solution to plastic micro molding, and can manufacture precision plastic parts with certificated qualities. Please contact us if you are looking for a micro injection molding company.
Micro Injection Molding Application — Electronics
THY Precision provides micro mold tooling and injection molds millions of parts for use in electronic devices including computers and tablets, hard drives, MP3 players, hearing aids, or any other mini sized plastic components of electronic devices. In addition to high-precision gears and electric bobbins, we also can micro-mold specialty products such as components for hearing aids, microphone components and any any components that made from plastic. As the technology changing, components in electronics devices are required to be lighter, smaller and more precision. Micro injection molding technique can provide a perfect solution to those tiny components.
With more than 10 years experience and ISO certification, we THY precision can be a trustable partner of precision plastic molding. Our production facilities include 15,000 square meter factory, class 100,000 cleanroom, automatic assembly system and strict inspection process. We pay attention to every part of production and commit to achieve customers' requirements. Contact us to leave your needs, we will reply soon and provide professional services on micro plastic injection molding.
THY Precision has got ISO13485 certification. With ISO13485 certification and class 100,000 clean room, we are able to manufacture medical grade precision plastic products including medical device components and disposable medical supplies such as plastic needles, syringe, injector cartridge… etc. Having both ISO13485 and ISO9001 certification, our product quality is guaranteed by the third person organization, and can be trusted. Contact us for further information and services, we welcome your inquiries anytime.
What is ISO 13485?
ISO13485 is a widely used standard for medical device quality management systems that comply with regulatory purposes. This standard ensures that THY Precision can meet specifications in the process of developing, producing, manufacturing plastic medical devices components and supplies. We apply micro injection mold technique in medical field for adapting the more and more precision medical treatment.