Novex Innovations
Device Division
Partner with Novex Innovations: Supporting Your Medical Device Production
Medical devices are considered a fundamental component of Health Systems; the health benefits they can provide continue to increase as they’re essential to prevent, diagnose, treat, and rehabilitate illnesses and diseases safely and effectively. The steps that involve medical device manufacturing, regulation, planning, assessment, acquisition, and management are complex but essential to guarantee their quality, safety, and compatibility with the settings in which they are used.
Novex Innovations is an experienced organization in the handling of medical devices and has a track record of resolving issues to drive a product toward approval for market launch. Our dedicated team of multi-disciplinary employees allows for a well-rounded assessment of a product and the potential roadblocks to avoid along the way.
We are dedicated to being your reliable and trustworthy partner in developing and manufacturing your medical products. Our team of experts will work closely with you to ensure the successful launch of your devices in the market.
We’re here to support you in designing your product for seamless manufacturing, ensuring the highest quality finished product. This paves the way for optimization and, ultimately, the best pricing for your medical product.
Through our commitment for continual improvement and meticulous change control, we diligently monitor your program(s) to deliver the optimal product for your clients. Rest assured, we are dedicated to providing nothing but the best.
From first articles, we produce health products for evaluation studies and validation activities. We routinely conduct a wide range of studies, including but not limited to, VDmax, dose audit, bioburden evaluation, accelerated/real-time aging studies, transportation studies, and package integrity.
With our extensive expertise in manufacturing medical devices, we pave the optimal path to market for your product. You can trust us to bring your vision to life!
Using a wide variety of packaging options, we can either accommodate your existing needs or provide options for the type of packaging best suited for your product.
We have extensive expertise in assembling medical devices, including the assembly and testing of MET approved electrical/electronic products. We deliver top-notch precision and quality in every step of the process.
When medical devices regulation matters, Novex Innovations is here to provide organizations with regulatory assistance so they can bring effective medical devices to market that meet regulatory requirements.
- FDA Registered.
- ISO 13485 Certified.
- Assembly of MET approved products.
- We are the sole manufacturers listed for several registered 510K products with many others under development.
Partner with Novex Innovations to ensure your health technology meets all of the required medical device regulation.
The Unmatched Expertise of Medical Device Production with Novex Innovations
Our medical device manufacturing and packaging are completed in ISO 5 clean air environments to ensure the utmost benefit to mitigate bioburden and/or endotoxin. Our device division has ample room for expansion to continue to grow as your product matures commercially.
Our main concentration lies in Class II and Class III devices, as well as devices associated with combination products combined with drugs or biological products. Additionally, we offer supportive components for Class I devices. The majority of devices produced at our facility are considered invasive in terms of delivery or extraction. Our biological media solutions preparation services are integrated with our medical device group to meet your specific requirements.
Due to our registration elected restrictions, we do not directly engage in device design. Our role entails evaluating the product from a processability perspective, focusing on developing a seamless and reproducible process that enhances the functionality and presentation of the final product.
The variety of medical devices that we work with allows for a broad range of assembly types such as UV gluing, clip assembly, inking application, and wiring of electronic and electrical components. Our in-house testing includes burst testing, creep testing, pressure retention, functionality test of devices, power/ current leakage tests, loss on drying, and/or Karl Fisher.
We go above and beyond to meet our client’s expectations and requirements when it comes to packaging. We offer a diverse range of options including vials, pouches, and various poly containers for primary packaging. But we don’t stop there! We also provide secondary packaging, which can be customized with your brand or left unbranded. We can deliver exceptional packaging solutions tailored to your needs.
Novex Innovations is your trusted partner, supporting you at every step of the journey – from product evaluation to packaging. Together, let’s embark on an exciting adventure!
Frequently Asked Questions
Novex Innovations owns its facility totaling approx. 150,000 square feet over two buildings.
Novex Innovations is located in Winston-Salem, North Carolina, USA.
Novex Innovations is a privately owned company with the ability to make quick decisions and be agile in accommodating customer’s needs.
From a device perspective, we will coordinate Vdmax studies, dose studies, transportation studies, real-time aging/accelerated aging studies, compatibility studies, and process validation activities. Bioburden, sterility, and B&F testing will establish baseline information for the support of ongoing quarterly dose audits.
With our level of experience, we offer valuable insights to our clients, guiding them toward what works best and what doesn’t. We can help you make informed decisions and achieve remarkable results!
Class I medical devices are those with the lowest risk. These devices are generally quite simple and typically do not require premarket clearance (such as bandages, tongue depressors). Class I medical devices can include products such as wheelchairs, crutches, surgical drapes, examination gloves, and shoulder immobilizers. These products must meet certain safety requirements to be sold in the US market and may require registration to ensure continued safety standards. We specialize in helping clients produce high-quality Class I medical devices that meet all regulatory requirements for market success!
Class II medical devices are those with a moderate risk. These medium to high-risk medical devices are typically more complex than Class I and require additional premarket review, such as FDA 510(k) clearance or premarket approval. Examples of Class II medical devices include inspection systems, infusion pumps, and sampling devices. Our team is well-versed in the design, development, and testing of these products to ensure that they meet all regulatory requirements for market entry. We can help you bring your Class II medical device product to life!
Class III medical equipment normally sustains life. These high-risk medical devices are incorporated into a person’s body and help to manage diseases. They make up 10% of all FDA-approved products. Some examples are implantable cardiomyocyte pacemakers and breast implants.
Discover Our Other Divisions
Drug Division
Novex Solutions provides expert services for biologic drug development and manufacturing, from laboratory to commercial supply. Our commitment to delivering exceptional results is unwavering.
With our stringent cGMP standards and proven track record of compliance with regulatory authorities, we are the trusted expert partner for biologic drugs, small molecule drugs, and other pharmaceuticals.
Learn about our Drug Division.
Biologics and Tissue Division
Novex Innovations’ Biological and Tissue Division provides comprehensive support for biologic programs, guiding them from the spark of an idea all the way to successful product commercialization.
Let us fuel your innovation and bring your vision to life!
Learn about our Biologics Division.
Distribution Division
We combine the power of human expertise and automation to create customized inventory management and fulfillment solutions.
Whether it's during busy seasons or when launching new products, we provide the flexibility to handle your product inventory and distribution needs under your brand.
Learn about our Distribution Division.Looking For A New Medical Devices Solution?
At Novex Innovations, we understand the complexities and challenges that come with developing and manufacturing medical devices. Our decades of experience, combined with our cutting-edge technology and commitment to quality, make us an ideal partner for your medical device development journey.
Our team of experts is well-versed in regulatory standards and patient safety. We are dedicated to ensuring the highest levels of compliance while optimizing the manufacturing and packaging processes. Whether you’re looking to develop Class I, II, or III medical devices, or even combination products, we can offer solutions tailored to your needs.
Our cleanroom environments ensure the highest level of cleanliness, while our diverse assembly capabilities enable us to handle a wide range of devices. We assess each product and design a process for ease of operation, reproducibility, functionality, and presentation, to ensure your medical device is of the highest quality and meets market demands.
For further information, let’s start a conversation about what you need.
