Benefits of 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. Since its inception, medical devices that are manufacturing with injection-molded plastic have contributed to a reduction in medical costs and increased patient safety.

Plastic Injection Molding for Medical Device manufacturing of components and devices using medical grade plastic materials that are durable, reliable and meet FDA regulations is the essence of medical injection molding. Medically graded plastic injection molding is utilized in manufacturing components such as medical components, beakers, test tubes, and laboratory equipments. These molds have the ability to meet the specifications and requirements of the medical device industry.

Benefits of Plastic Injection Molding for Medical Device 

Since medical device plastics provide increased versatility and can be combined with metal to create enhanced medical product attributes, medical grade plastics have become the preferred material for numerous types of electronic medical devices. Some of the advantages that medical injection molding companies can provide, include: 

• Improved ergonomics
• Reduced weight
• Increased functionality
• Lower cost
• Decreased burden of sterilization

Types of Plastic Injection Molding for Medical Device  

There are basically two categories of injection molding products that are typically produced for the medical market: certification-intensive products and those that are not extensively regulated. Original Equipment Manufacturers (OEM’s) create devices that are classified by the FDA according to the nature of their function, and the function of a medical product is what dictates every aspect of its production, including how its plastic parts will be molded.

Selecting The Plastic Injection Molding for Medical Device  Materials

There are many different grades of plastics available for injection molding and each one has strengths and weaknesses that need to be considered. Below are a couple factors that need to be top of mind when choosing a plastic material for your medical device.

When choosing a medical grade Plastic Injection Molding for Medical Device , it is important to select one that has the proper strength. Plastic resins come in many different strengths, so it is important that you choose one that fits the specification of your medical device. Choosing a material that is not strong enough can result in the medical device failing during use.

Read More - Medical Device manufacturers 

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Phone  no -  93702 83428

Mail id – enquiry@operonstrategist.com

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If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device   

Classifying a Class III Medical Device

For Classifying a Class III Medical Device the FDA established certain regulatory controls in the form of general controls and special controls. The classification of medical devices (Class I, Class II or Class III) will determine the type of regulatory controls the FDA imposes to ensure the device’s safety and effectiveness before being placed into commercial distribution in the US.

When it comes to medical device classification per FDA requirements, it essentially comes down to the level of benefit and risk posed by the product and the level of control needed to ensure adequate safety. Class I devices present minimal harm to the patient and are generally simple in design, while class II poses a higher degree of risk. Classifying a Class III Medical Device applies to the high-risk types of medical devices that are deemed very important to health or sustaining life.

• Regardless of the specific Classifying a Class III Medical Device, if clinical data is required for clearance or approval, the clinical investigation must be conducted one of two ways:

1. If it poses a Significant Risk (SR), it must follow the FDA’s Investigational Device Exemption (IDE) protocol
2. If it does not pose a significant risk, it will go before an Investigational Review Board

• Examples of the types of medical devices that fall under class III include:

1. Cochlear implants
2. Implantable pacemaker pulse-generator
3. Renal stents
4. Wearable automated external defibrillators
5. High frequency ventilators

For Classifying a Class III Medical Device, the manufacturer will undergo the highest level of FDA scrutiny and associated costs. The majority of devices are considered a class I or class II, with only 10% receiving the class III designation.

• Knowing how your medical device is classified matters for the following reasons:

1. Product classification will determine what you have to do before you can sell your product.
2. Product classification will help you establish requirements during the product development phase, specifically design controls.
3. Product classification is an important component in determining how much it will cost to bring your device to market and give you some idea of how long it will take.

Read More -  Classifying a Class III Medical Device

Contact details –

Phone  no -  9325283428

Mail id – enquiry@operonstrategist.com

Read More Article - 

1. Orthopedic Implants Manufacturing

2. disposable syringe manufacturers

3. Dental Implants Manufacturing

4.Blood Collection Tubes Manufacturing

5.How to start the Manufacturing of Disposable Syringes

If  You Want Medical Devices Services Consultation For Following.

1. Medical Device Consulting 
2. cdsco registration 
3. FDA 510k Clearance 
4. ce mark medical device 
5. CDSCO Manufacturing License 
6. CDSCO import license 
7. TURNKEY PROJECT CONSULTANT 
8. medical device manufacturing 
9. iso 15378 certification 
10. 21 cfr part 210 and 211 
11. ISO 13485 Medical Device Consultant 
12. Primary Packaging Turnkey Project Consultant 
13. Clean Room Design Consultant 
14. manufacturing site conceptualization 
15. Market Analysis and feasibility for Medical Devices 
16. manufacturing plant layout design 
17. medical device design and development 
18. DMF file submission guideline 
19. 21 cfr part 820 
20. qms certification services 
21. capa management 
22. design control requirements 
23. medical device process validation 
24. combination product 
25. continuous improvement program 
26. Medical Device Compliance & Regulatory Services 
27. Cdsco India authorized agent for medical device