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Benefits of Class II Medical Device Contract Manufacturing

Aug 17, 2021 | Medical Device, Regulatory

Partnering with a  Class II Medical Device Manufacturing Company Saves Time and Money

Class II medical device manufacturing requires precision, compliance, and efficiency. Today, companies must meet increasing market demands while maintaining high-quality standards. But, with so many moving parts, it can be difficult to meet these requirements. A solution to this challenge includes medical device contract manufacturing.

By partnering with specialized contract manufacturers, companies save significant resources. It’s usually faster and cheaper to work with a contract manufacturer, rather than keeping production in-house. But the advantages don’t stop there. Here, we’ll explore the benefits of Class II medical device contract manufacturing and help you determine if it’s right for your business.

Overview of Class II Medical Device Manufacturing

Class II medical devices pose a moderate risk to the patient. Thus, they must adhere to strict regulatory requirements. Contract manufacturers specializing in Class II medical devices are well-versed in navigating the complex regulatory landscape, including compliance with the FDA’s Quality System Regulation (QSR) and ISO 13485 standards.

Benefits of Class II Medical Device Contract Manufacturing


When you work with a contract manufacturer, you can dramatically reduce costs, allowing you to allocate resources to other critical areas. Additionally, contract manufacturers often buy materials in bulk, which could result in discounted material costs.

Accelerated Time to Market

Time to market is a crucial factor in the medical device industry. Competition is fierce and technological advancements may quickly render products obsolete. Class II medical device contract manufacturers have efficient production processes, which allows them to deliver products faster. Working with a contract manufacturer can help you seize market opportunities and generate revenue sooner.

Better Quality and Compliance

Maintaining high-quality standards and compliance within regulatory requirements is paramount in the medical device industry. Class II medical device manufacturers specialize in manufacturing processes that comply with industry regulations and quality management systems. Extensive experience and rigorous quality control measures ensure the production of reliable and safe devices.

Greater Flexibility and Scalability

Class II medical device contract manufacturing offers greater scalability and flexibility than in-house manufacturing. Contract manufacturers already have robust infrastructure and resources, allowing them to quickly scale production up or down based on demand fluctuations. This allows you to promptly respond to market shifts, without the need for significant capital investments or resource reallocation.

Risk Mitigation

Partnering with a contract manufacturer can reduce the risk for your operation. A contract manufacturer has established quality management systems and risk assessment processes in place, minimizing the chance of product failure, recalls, or regulatory non-compliance.

Access to Specialized Expertise

Contract manufacturers often specialize in specific areas of medical device manufacturing. This specialization allows them to develop deep expertise and knowledge in particular technologies, processes, or product types. Companies can leverage this expertise to improve product design, manufacturing efficiency, and overall product quality.

Supply Chain Optimization

Managing the supply chain can be complex and time-consuming for medical device companies. Contract manufacturers can efficiently source materials, components, and equipment, which ensures a smooth flow of resources throughout the manufacturing process. Leveraging a contract manufacturer can optimize procurement processes, reduce lead times, minimize inventory costs, and mitigate supply chain risks.

Regulatory Compliance and Documentation Assistance

Navigating the regulatory landscape is a critical aspect of medical device contract manufacturing. An experienced contract manufacturer has in-depth knowledge and experience in regulatory compliance, including FDA regulations, international standards, and documentation requirements. A great partner can help you maintain the necessary documentation, such as technical files, design history files, and regulatory submissions.

Looking for a Class II Medical Device Contract Manufacturing Partner? Work with the Best

When you need an experienced Class II medical device contract manufacturing partner, turn to WuXi AppTec. For over 20 years, we’ve been helping companies create high-quality Class II medical devices. We’re eager to help you with your next project.

With so many contract manufacturing companies out there, why should you choose WuXi AppTec? We maintain rigid industry certifications that help us develop high-quality medical devices and streamline the approval process. We adhere to good manufacturing practices (GMP) . Additionally, our St. Paul, Minnesota location is ISO 13485 certified, meets ISO 14644-1 class 7 cleanroom standards, and maintains accreditation with the American Association of Tissue Banks (AATB). We also maintain global regulatory compliance with the FDA.

Let’s Make Something Great Together

Are you a large corporation looking for a strategic contract manufacturing partner for your smaller or aging lines? Are you a small team looking for expertise for production on your proposed device? No matter your organization’s size, we’re here to help. Learn more about our services — and request a no-obligation consultation — here.

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