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Special Packaging Injection Molding Machine

Medical Devices - Bright Plastics - ISO 13485:2003 certified …

Bright Plastics is ISO 13485:2003 certified for medical device manufacturing, as well as FDA-registered as a medical device manufacturing facility. Our ISO 7 (Class 10,000) cleanroom features four all-electric molding machines. These qualifications, combined with our scientific injection molding process, position Bright Plastics to work with a diversity of medical and pharmaceutical companies.

Estimated Reading Time: 2 mins

ISO 13485/9001 Certification: A Hybrid Quality Management …

Since February 1999, when Matrix Plastic Products first acquired ISO 9001 certification, the quality of our work and our responsiveness to customers had earned us an excellent reputation. We are now adapting our ISO 9001 QMS to comply with ISO 13485, the quality standard specific to the medical device …

Estimated Reading Time: 5 mins

ISO Certification | Plastic Ingenuity

A quality management system for medical device and pharmaceutical packaging solutions. Plastic Ingenuity is proud to be recognized as an ISO 13485 certified company. This certification ensures that the design and manufacture of thermoformed plastic packaging complies with the applicable regulatory requirements for the medical device industry. PI is our go-to supplier—especially if a short lead time …

Benefits of ISO 13485 Certification for Medical Device …

Reducing The Likelihood of Longstanding Issues

ISO - ISO 13485 — Medical devices

ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.

Injection molding and plastics for medical devices - Medical …

Jun 20, 2016 · Injection molding and plastics for medical devices. FDA registration and ISO 13485 certification are required to maintain quality system operational standards. Medical device manufacturers can easily avoid expense by choosing an injection molder experience in the medical …

Plastic Injection Molding: ISO9001 or ISO13485?

May 11, 2010 · ISO 9001 : 2008 is best and you can still supply to medical customers your plastic moulded parts perhaps as general engineering plastic parts. The title of ISO 13485 can clearly tell you what this standard intendes " Medical devices - Quality management systems - requirements for regulatory purpose. ". D.

Medical Products - Cleanroom RequirementsAug 13, 2020Is ISO 9001 necessary if ISO 13485 certified?Jun 03, 2015How to find definitions from ISO 9001 when implementing ISO 13485?Feb 25, 2009Validation Requirements: ISO 9001 vs. ISO 13485?Mar 17, 2007See more results

Injection Molding and Plastics for Medical Devices

Sep 18, 2020 · What certification is important for medical device manufacturers? A. ISO 13485 is built on the ISO 9001 framework but adds industry-specific language for medical device manufacturers. ISO 13485 compliance can help a medical device manufacturer to be in compliance with FDA and European medical device quality standards. Q.

Medical Device | Injection Molding | Plastic Machining | Aero …

Aero-Plastics is an ISO13485:2016 certified manufacturer of injection molded and non-metallic machined components for the medical device and biotechnology industry.

Medical Injection Molding - ISO 13485 certified and FDA …

Taurus Engineering is an ISO 13485 certified and FDA registered manufacturer specializing in medical injection molding, contract manufacturing, DFM, prototype molding, production molding, and value added assembly. The medical device market is a constantly evolving industry where standards are always updating, and the need for effectiveness and efficiency is paramount.

Estimated Reading Time: 2 mins

ISO 13485 revision: What it means for medical device OEMs …

Jan 03, 2018 · The global standard for medical device quality management systems recently underwent its first revision since 2003, and it contains a number of changes that must be taken into account by medical device manufacturers and their critical suppliers. And, yes, there is a deadline: Companies must show compliance to ISO 13485:2016 by March 1, 2019.

Estimated Reading Time: 7 mins

ISO 13485 and Medical Device Manufacturing: Your …

Nov 06, 2018 · BMP is a global manufacturer of plastic medical devices that are used in research and medical diagnostic laboratories. As an Original Equipment Manufacturer (OEM) of medical devices, adherence to ISO 13485 has been critical to its success. BMP implemented a QMS that met the requirements of certification for ISO 13485 in 2016.

Estimated Reading Time: 4 mins

Clariant MEVOPUR® Medical Compounding Plants Certified …

ISO 13485-2016 set to become mandatory for device manufacturers. Compliant suppliers reduce risk for users of plastic materials. Three sites in U.S.A., Europe and Asia. Muttenz, February 1, 2019 – Clariant, a world leader in specialty chemicals, announces that its recently expanded facility in Lewiston Maine, and two other sites in Malmo, Sweden, and Singapore, have been certified to the stringent new quality …

Estimated Reading Time: 5 mins

Why Clean Room Manufacturing Matters For Medical Device …

Dec 21, 2016 · MDI’s ISO 13485 certification means it can serve medical device manufacturers around the world. ISO 13485, in particular, was created to meet the quality system requirements in Australia, Japan, and Canada. In Europe, it is the de facto standard. Companies that meet this certification have also laid the groundwork to serve some additional ...

Medical Device Molding and Tooling / ISO 13485 …

Medical Device Molding and Tooling / ISO 13485 Certification. Toggle navigation. Home. Capabilities. Materials. Case Study. ISO 13485. Request A Quote.

Clariant’s Facilities Certified with New Quality Standard for …

Feb 04, 2019 · Clariant’s Facilities Certified with New Quality Standard for Plastic Medical Devices. The new stringent quality standard ISO 13485-2016 is expected to become mandatory for device manufacturers. The firm has adopted this strategy across three of its sites in USA, Europe and Asia. Lewiston medical compounding site with ‘all polymer ...

Estimated Reading Time: 4 mins

Medical Device Assembly - MDI

Outsourced medical device assembly, packaging and kitting — ISO 13485:2016 certified and FDA registered. Class 10,000 and ISO 14644-1:1999 White Room.

Plastic Injection Molding For Medical Device Industry | …

Apr 25, 2019 · The guidelines are covered under the 21 code of Federal Regulation Part 820 (covering Medical Devices) and cover components that are distributed to a finished device manufacturer or devices and components that are packaged or labeled for commercial distribution of health-related purposes for an end consumer. What is ISO 13485?

Estimated Reading Time: 7 mins

C E R T I F I C A T E - Tegra Medical | Contract …

Solutions for Metal and Plastic Components, Assemblies Scope of Certificate: Contract Manufacturer Providing Process Engineering and Devices Serving the Medical Device, Diagnostic and Life Sciences Industries Standard: ISO 13485:2016 The Certification Body of TÜV SÜD America Inc. certifies that the company mentioned above has established and is

Medical Injection Molding Services at Protolabs

ISO 13485-certified injection molding service for plastic medical device components. Our medical molding service allows you to leverage the speed-in-development you are used to in the high-requirement environment of the medical space. Our team of medical molding manufacturing experts helps you take FDA Class I and II devices, or non-implantable components, quickly from prototype to production and …

EwellPlastics specializes in the design, development and …

EwellPlastics specializes in collaborative development and manufacturing of various medical consumables 30 years of experience in plastic injection molding production and manufacturing,EwellPlastics Co., Ltd. was established in 1989 and has more than 30 years of plastic injection molding manufacturing experience.Specializing in the collaborative development and manufacturing of various plastic ...

Modern Plastics ISO Certification | Modern Plastics

Modern Plastics is ISO CERTIFIED: ISO 9001:2015 – Certified Quality Management Systems; ISO 13485:2016 – Certified for Medical Devices; Modern Plastics is certified to ISO 9001 and ISO 13485 by Perry Johnson Registrars, Inc. Our last full audit was conducted in August 2017.

Medical Injection Molding | Device Molding | ISO 13485

Xometry's network has decades of experience with plastic injection molding for parts used in medical applications. Our strength is helping our customers make complex parts that our competitors often can't make. We offer: ISO 13485 and ISO 9001 registered facilities. ISO Class 8 …

Turnkey Solutions for Your Medical Device Development. - …

Our medical plastic injection molding capabilities include: Medical Device Design Development and Assistance. Design for Manufacturability. Medical Device Molding. Cleanroom Molding and Assembly, Class 8. ISO 13485 Registered and Compliant. FDA Registered. RJG Certified Mold Builder and Tryout Facility. Cavity Pressure Sensing and Scientific Injection Molding.

Estimated Reading Time: 50 secs

Medical Injection Molding - QFC Plastics

QFC Plastics is an ISO 9001:2015 and ISO 13485:2016 certified medical injection molding company. We are also FDA registered for the manufacturing of medical devices and plastic molded components. We have an ISO Class 100,000 clean room for medical device assembly and inspection. We also have a climate controlled manufacturing environment area.

Medical Devices | Univac - Pursue Excellence for Life

Our medical device and life sciences manufacturing services include molding production, assembly, and packaging capabilities in a Class 7 and 8 cleanroom environment. We are ISO 13485 certified in all our facilities, and operate under good manufacturing practices for both high volume disposables and low volume equipment needs.

Medical Device Manufacturing Company in India, …

ISO 13485 – 2016 certified & USFDA approved Medical Device manufacturing company. Exporting Catheters in a volume of 2 to 3 Forty Feet Containers /month to USA. Cost Effective Contract Manufacturer of Plastic Components. Certified with ISO 13485 : 2016.

Injection Molding Quality Standards | ISO 13485 Certified

Springboard is ISO 13485 certified. “ISO 13485: Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes” is an ISO standard that states the requirements for a comprehensive quality management system for the design/manufacture of medical components and sub-assemblies. As stated on ISO, the ISO 13485 standard “specifies requirements for a quality …

Medical Device | Injection Molding | Plastic Machining | Aero-Plastics Inc.

Aero-Plastics is an ISO13485:2016 certified manufacturer of injection molded and non-metallic machined components for the medical device and biotechnology industry. Our manufacturing equipment produces components from a variety of FDA-approved and …

Medical Device Molding and Tooling / ISO 13485 Certification - J&L Plastic …

Medical Device Molding and Tooling / ISO 13485 Certification. Toggle navigation. Home. Capabilities. Materials. Case Study. ISO 13485. Request A Quote.

Clariant’s Facilities Certified with New Quality Standard for Plastic Medical Devices

Feb 04, 2019 · Clariant’s Facilities Certified with New Quality Standard for Plastic Medical Devices. The new stringent quality standard ISO 13485-2016 is expected to become mandatory for device manufacturers. The firm has adopted this strategy across three of its sites in USA, Europe and Asia. Lewiston medical …

MOS PLASTICS – KS Group - Plastic Injection Molding and Medical Plastic …

MOS Plastics is ISO 13485 certified and FDA registered regional contract manufacturer offering 3 facilities in California and Mexi In the healthcare industry, MOS Plastics is a world leader when it comes to Medical and Diagnostic injection molding. We are a top-tier, preferred supplier for well-respected medical device and technology leaders ...

Medical Device Clean Room Manufacturing | Genesis …

Two certified Class 7 Medical Clean Rooms are available around the clock depending on production demand. Genesis is an ISO 13485 certified contract manufacturer providing RF welding and heat sealing applications of plastic products. Meet FDA requirements for contract manufacturing of Class I, Class II and Class III medical devices and components.

Plastic Injection Molding For Medical Device Industry | Sealect Plastics

Apr 25, 2019 · The guidelines are covered under the 21 code of Federal Regulation Part 820 (covering Medical Devices) and cover components that are distributed to a finished device manufacturer or devices and components that are packaged or labeled for commercial distribution of health-related purposes for an end consumer. What is ISO 13485?

PrinterPrezz Announces ISO 13485:2016 Certification for 3D Printing of Medical Devices ...

Jun 19, 2019 · ISO 13485:2016 certification is a requirement for regulatory purposes and is an international standard that outlines the requirements for a quality management system specific to the medical devices industry. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer ...

Medical Device Contract Manufacturing | East West Industries

With ISO 13485:2016 certification, our factory is qualified to manufacture plastic and metal parts and electro-mechanical assemblies for the medical device industry. Our Medical Device Manufacturing Capabilities Include: Plastics - Injection Molding, Insert Molding, Over-Molding, Pad Printing, Ultra Sonic Welding, and Assembly

Quality System and Certifications | Mueller Corp

ISO 13485 is the quality management system standard for medical device manufacturers and their sub-tier suppliers and subcontractors. Based on the ISO 9001 standard, ISO 13485 includes additional requirements for medical device manufacturers to demonstrate their intent to comply with applicable regulatory and statutory requirements.

Medical Device & Equipment Manufacturing - Control …

All of our staff understands the quality is as much an attitude as a process. We are equally capable in providing medical equipment, or medical devices. We are ISO 13485 and ISO 9001-certified, both the USA & and our Asian Facilities. Secondary Coatings / Finishes. E-Coat; Wet Coats; Clean Room Powder Coating; Electro & Electrocess & Vacuum ...

ISO 13485: How can it help with MDR compliance?

Mar 09, 2020 · ISO 13485, on the other hand, is an internationally recognized standard for creating a QMS for medical device companies anywhere in the world. ISO 13485 requirements can be used by any organization that needs to demonstrate that it produces medical devices and provides related services that consistently meet customer and regulatory requirements.

Expertise in Medical Device Contract Manufacturing - Plastic Injection Molding, Medical ...

Expertise in Medical Device Contract Manufacturing. C&J Industries is an ISO 9001:2015 and ISO 13485:2016 certified medical contract manufacturing company. We are also FDA registered for the manufacture of medical devices and plastic injection molded components.

ISO / QMS - Matrix Plastic Products

Oct 02, 2019 · Because ISO 13485 certification is required by most of our medical device customers, and ISO 9001 certification is required by most of our non-medical device customers. While the largest segment of our business is medical, we do want to continue serving other key industries requiring a similar degree of quality and precision.

Matrix Plastic Products | Injection Molding and Moldmaking …

Matrix Plastic Products is a quality-driven custom manufacturer specializing in injection molding, moldmaking & assembly with surgical precision. Our ISO 13485:2016 certified company partners with medical device manufacturers to engineer, tool up, and …

Plastics Materials & Processing for Medical Devices – Online - First Polymer – Training ...

This session will cover the process of validation for regulated industries, with particular focus on validation for the manufacture of medical devices and the requirements of ISO EN 13485 and FDA QSR. Regulations that govern the medical device/ healthcare sector – ISO 13485 , FDA requirements – Class I, II and III devices

Plastic Injection Molding for Medical Device

Plastic Injection Molding for Medical Device is a growing, cost-effective method of manufacturing devices and parts. Along with its ability to produce complex designs that meet the stringent cleanliness requirements, medical-grade plastic injection molding offers high tensile strength as well as chemical and high-temperature tolerances.

Free Online ISO 13485 Certification Training Course | Alison

Sep 17, 2021 · Publisher: S. M. Waqas Imam. This free online ISO 13485 certification training course will teach you about quality management systems for medical devices. You will study the ISO 13485:2016 standard, learn how it was developed, and look into the practical steps to company certification on ISO 13485. You will cover the types of available personal ...

Disposable Cold Chain Packaging Medical Ice Bags CE ISO13485 Certificated

High quality Disposable Cold Chain Packaging Medical Ice Bags CE ISO13485 Certificated from China, China's leading Cold Chain Packaging product market, With strict quality control Cold Chain Packaging factories, Producing high quality Disposable Cold Chain Packaging Medical Ice Bags CE ISO13485 Certificated products.

Manufacturing medical devices to ISO 13485:2016

Jul 01, 2019 · ISO 13485 and European Union medical device regulatory requirements. Complying with ISO 13485 standards and gaining the certification is also a first step towards complying with the European regulations and requirements for Medical Devices and in vitro Diagnostic Medical Devices (EU Directives 93/42/EEC, 90/385/EEC and 98/79/EEC).

C E R T I F I C A T E - Tegra Medical | Contract …

Solutions for Metal and Plastic Components, Assemblies Scope of Certificate: Contract Manufacturer Providing Process Engineering and Devices Serving the Medical Device, Diagnostic and Life Sciences Industries Standard: ISO 13485:2016 The Certification Body of TÜV SÜD America Inc. certifies that the company mentioned above has established and is

C&J Industries | Medical Device Supplier Directory

C&J Industries is a single source for all your high precision medical contract manufacturing and plastic injection molding needs. We are an ISO 13485:2003 certified Medical Device Manufacturer and Medical Injection Molder who has been FDA registered since 1981.

Medical Industry - Star Rapid

To support the needs of the medical industry, we offer a range of materials including titanium, stainless steel, TPE, POM, PEEK, ABS, nylon, silicone rubber and more. Our facility is fully certified to ISO 13485:2016, 9001:2015, 14001:2015 and 45001:2018 standards.

Medical Device Manufacturing Transfer out of China - VEM Medical

VEM proposed a production transfer of plastic injection molding and assembly operations from the supplier in China to VEM’s ISO 13485 certified facility in Thailand. This facility is equipped with a Class 100,000 cleanroom. VEM has been manufacturing medical devices in Thailand for 13 years. The operation is located 30 minutes from Thailand ...

ISO 13485 Certified Contract Manufacturer | Genesis Plastics Welding

ISO 13485 Certified Contract Manufacturer. As an ISO 13485:2016 certified contract manufacturer, Genesis Plastics Welding maintains the following quality standards, registrations, and certifications: ISO 13485:2016 Certificate. Class 7 Clean Room Certification (Room 1)

ISO 13485 Medical Devices | International Associates

Jun 11, 2020 · Non-Active Dental Devices & Accessories: Non-active dental devices/equipment & instruments, Dental materials & Dental implants; Other Non-Active Medical Devices; For all enquiries in relation to UKAS Accredited ISO 13485 Certification of your Medical Device Quality Management System please send an email to [email protected] or call +44 (0)1413 ...

Medical injection molding plastic manufacturer …

Medical plastic molding in class 1000000 ISO 8 clean room, ISO 13485-2016 Certified medical device molding factory, 15+ years experience project manager work with you, Artificial limb, Surgery, Labware plastic injection molding, Ventilator plastic companents …

Medical Device Manufacturer Malaysia | Unip Berhad

Unip Plastic Industries Sdn. Bhd. is an ISO 13485 certified manufacturer of Medical Devices. Our production is done in our 100K cleanroom. Our fully electric Japanese make presses range from 30 tons to 140 tons. We also have 2K indexing presses. We offer a complete solution from initial idea to approved design and finally to mass production.

Medical Injection molding services Suppliers | Medical Device …

We are ISO 13485 certified, Custom Plastic Injection Molding facility of medical device components. Precision manufacturing with scientific molding practices encompasses horizontal, vertical, and insert molding. Comprehensive tool room capabilities include mold design, tool constru...

PTCA Medical Balloon Inflation Device Medical Consumable …

Quality Medical Balloon Inflation Device manufacturers & exporter - buy PTCA Medical Balloon Inflation Device Medical Consumable Indeflator from China manufacturer. Jiangsu ChangMei Medtech Co., Ltd. Improve physician operating effiency, improve patient quality of life. ... Certification: CE/ISO13485: Instrument Classification:

ISO 13485 Certification in Singapore | ISO Certification …

ISO 13485:2016 is a Quality Management System standard for Medical Devices, has been harmonized with European Medical Devices Directives i.e MDD, AIMDD and IVDD. EN ISO 13485:2012 is now updated as ISO 13485:2016, in the EU Official Journal, with the date of ‘cessation of presumption of conformity’ of EN ISO 13485:2012 stated as 31 March 2019.

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