Consistency is defined as the achievement of a level of performance that does not vary greatly in quality over time. While there are many factors that OEMs should consider when partnering with a silicone injection molder – consistency is certainly at the top of the list! This is especially true for OEMs that supply medical parts and devices to the healthcare industry – you simply cannot afford to cut corners when it comes to consistency and quality as these products are often critical to the health of the individual using them.

Due to its chemical inertness, durability, stability, and low toxicity, medical grade silicone is an excellent material for implantable and other medical devices and its use throughout the healthcare sector continues to grow. The healthcare industry has high expectations for its devices – requiring compliance with tight tolerances and cleanliness requirements that offer little room for error. A molder that has a high level of quality and repeatability in its medical device production is able to deliver consistent products to customers – becoming a trusted partner! Meeting an OEM’s specifications and requirements for a given device must be the top priority for every injection molder. From both the supplier and OEM perspectives, inconsistency and poor quality can result in various negative outcomes such as slower time to market, customer complaints, tainted reputation, strained supplier-OEM relationship – and worst of all, customer loss or harm! For these reasons, consistency and quality matter most in medical silicone injection molding!

Before partnering with an injection molder, OEMs should have a firm understanding of their quality program – this is an area where excellent injection molders stand out from their competition. A silicone injection molder’s quality planning and assurance program is more than just meeting the requisite ISO and FDA requirements – it represents their proven way to ensure consistent quality of their injection molded parts. A sound quality program demonstrates that the molder monitors the effectiveness of their supply chain and demonstrates traceability related to regulations of materials and finished goods – enabling the production of medical products with consistency and repeatability.

ProMed’s Commitment to Quality

Partnering with an experienced injection molder like ProMed allows for the necessary production planning needed to meet all of the necessary regulatory, quality, and commercial standards. ProMed understands the importance of quality to your success. That is why quality is embraced every step of the way to create a product that will assure confidence in your products. Our work force is highly specialized in the manufacturing and quality requirements of medical products, much of which go into the long-term implantable market space. Every employee at ProMed is trained with the idea that quality is their most important responsibility.

Our equipment utilizes cost-effective, high-end molding technology to keep operating expenses down while producing parts with an extremely high level of precision and repeatability. Our tools are designed and manufactured to exacting tolerances. Expert toolmakers use high-tech design software and machining centers to produce molds that are durable and dimensionally repeatable from cavity-to-cavity, part-to-part!

We are an approved, certified supplier to many of the top medical device manufacturers in the world. All ProMed facilities go through routine audits by our ISO registrars and customers. Below is a sample of the standards we meet.

 

·      ISO:13485 – 2016 certified ·      ISO Class 7 Clean Room
·      ISO:17025 certified ·      REACH and ROHS compliant
·      FDA 21 CFR 820, 210/211 and part 4 compliant

ProMed’s Silicone Injection Molding Capabilities

ProMed was founded in 1989 to address an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We have garnered a reputation as the world benchmark of implantable silicone components and assemblies – and are one of few companies in the world to provide contract manufacturing of drug-eluting products.

ProMed has expertise in working with the full spectrum of silicones covering a wide range of properties and characteristics. We will assist in your material selection to help ensure all design requirements are met. Our manufacturing facilities and equipment are designed for a single purpose—to mold medical and implantable silicone, combination components, and bio-material grade plastics with uncompromising quality and service. We currently have four divisions that are located within two manufacturing sites. All are certified class 10,000 / ISO Class 7 cleanrooms.

We can identify the right manufacturing solution for any project. We have extensive experience in a wide range of injection molding techniques including:

  • Automated Injection Molding
  • Multi-cavity tooling
  • Micro molds and micro molding
  • Servo-controlled de-molding capabilities
  • Insert molds, overmolds, and automation integration
  • Transfer molding
  • Compression molding

Contact ProMed today at 763-331-3800 to discuss your next medical molding project.

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Why Consistency Matters Most in Medical Silicone Injection Molding
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Why Consistency Matters Most in Medical Silicone Injection Molding
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Consistency is defined as the achievement of a level of performance that does not vary greatly in quality over time. While there are many factors that OEMs should consider when partnering with a silicone injection molder ......
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ProMed Molding
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