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The Complete Guide to Class II Medical Device Development

Apr 17, 2021 | Medical Device, Regulatory

The Step-by-Step Guide to Creating a Life-Changing Class II Medical Device

Navigating the Class II medical device development process can be overwhelming. With so much to do, how do you know where to start? We’ve outlined a step-by-step guide, allowing you to understand the key action items and get started on your medical device today.

What is a Class II Medical Device?

Class II medical devices are considered to have moderate risk levels and are subject to regulatory controls to ensure their safety and effectiveness. Examples include blood pressure cuffs, syringes, blood transfusion devices, powered wheelchairs, and more. These medical devices are regulated by authorities such as the United States Food and Drug Administration (FDA) and the European Union’s Medical Device Regulation (MDR).

Phases of Class II Medical Device Development

Now that we’ve gone over the definition of Class II medical devices, let’s go over how they’re made.

Step One: Conceptualization and Research

The conceptualization and research phase involves identifying a need or problem and conducting research to gather relevant information. This information will define the device’s design requirements. Typically, there are a few phases of this process:

Needs Assessment

During this process, you’ll identify a need in the marketplace. You’ll gather input from healthcare professionals, patients, or other stakeholders to understand the challenges and requirements in the specific area of focus.

Market Research

Completing market research allows you to assess existing solutions, competitive products, and potential market size. By the end, you’ll have an understanding of how your medical device might perform in the market.

User and Regulatory Requirements

In this phase, you’ll define the intended users of the device so you can understand their specific needs. You may consider factors such as usability, ergonomics, safety, and any specific interface requirements. You’ll also research the applicable regulatory requirements in the target markets.

Intellectual Property Evaluation

This is perhaps the most important step in the conceptualization and research process. Intellectual property evaluation involves evaluating existing patents and intellectual property rights to ensure the proposed device doesn’t infringe upon protected technology.

Step Two: Design and Development

During this process, you’ll translate your device’s design into a tangible product or system. These are the stages you can expect:


Based on the design inputs you found in the conceptualization stage, engineers and designers create detailed design specifications and drawings. With their help, you’ll also select appropriate materials, determine dimensions, and create 3D models.


This is the stage where your medical device comes to life. You and your design team will build physical prototypes using CAD software.

Risk Management

The risk management phase is an extremely important step in the design and development phase. You’ll perform a comprehensive risk analysis and integrate risk management strategies into the device’s design.

Step Three: Verification and Validation

Design Verification and Validation

During this process, you’ll conduct verification activities to ensure the design meets the specified requirements. You’ll also validate the device design to ensure it meets the intended use and performs effectively and safely.

Human Factors Engineering

The human factors engineering process is designed to incorporate feedback from users. With this data, you can optimize the device’s user interface, instructions for use, and overall user experience.

Design Freeze

Putting your device into a “design freeze” means no more changes can be made to the product. From here, you’ll move on to the approval process phase.

Step Four: The Approval Process

The approval process varies depending on the regulatory jurisdiction. Usually, you can expect to prepare a premarket notification 510(k) submission before submitting your device for review by a regulatory body.

Step Five: Clinical Trials

This is a crucial step in assessing the safety and effectiveness of the device in a controlled clinical setting. These are the steps you can expect to complete:

Study Design

Your clinical trial must answer hard-hitting questions to ensure the device is safe for patient use. Your study design should define the objectives, endpoints, and more for the clinical trial.

Ethical Considerations and Regulatory Approval

Once you’ve determined your study design considerations, you must submit them to relevant ethics committees and review boards. They will determine whether your clinical trial is moral and can be conducted on human patients.

Patient Recruitment

When your study design is approved, it’s time to recruit patients for the study. Establish partnerships with healthcare professionals that specialize in the medical condition or procedure related to the device. These professionals can help identify potential participants. You should also create informative materials that clearly explain the purpose and benefits of the study. You can pass these out to healthcare professionals, patient advocacy groups, or other referral networks to attract patients.

Data Collection, Monitoring, and Analysis

During and after the clinical trial, you’ll track data that you’ve outlined in the study design. With this data, you’ll conduct an analysis to ensure the device works properly.

Results and Publication

After completing the clinical trial, there are several key publications that researchers aim to produce. These involve a clinical trial protocol, clinical trial results, systematic reviews and meta-analyses, subgroup analyses and secondary outcomes, adverse events and safety reports, and economic evaluations.

Step Six: Manufacturing

Manufacturing involves the setup and execution of the production process to manufacture the device in a consistent and controlled manner. Before you start the manufacturing process, there are a few steps you need to complete:

Supplier Qualification

You must have a high-quality manufacturing partner to ensure quality products. During this process, you’ll identify and qualify suppliers for the necessary components, raw materials, and sub-assemblies.

Process Validation

Once you’ve chosen your supplier, it’s time to validate their process. Process validation activities demonstrate that the manufacturing process consistently produces devices that meet the predefined specifications.

Quality Control

Lastly, you’ll establish a comprehensive quality control system to monitor and ensure the quality of your manufactured devices. Usually, your manufacturer will already have quality control options in place.

Step Seven: Post-Market Surveillance

Post-market surveillance for Class II medical devices refers to the ongoing monitoring and evaluation of the devices after they have been placed on the market. The purpose is to identify and address any potential risks, adverse events, or performance issues associated with the devices. These are some key aspects of post-market surveillance:

Adverse Event Reporting

Healthcare providers and users are encouraged to report any adverse events or incidents related to the use of the device. Adverse events can include device malfunctions, patient injuries, or any other unexpected or harmful outcomes. These reports help identify potential safety issues and trigger further investigations or actions.

Complaint Monitoring

You’ll establish a system to monitor and analyze complaints received from users or healthcare professionals regarding the device’s performance, usability, or safety. This can help you identify any patterns or recurring issues that may require attention.

Post-Market Clinical Follow-Up

These studies are conducted to collect additional clinical data on the device’s performance and safety in real-world use. These studies may involve a larger patient population or longer follow-up periods than the pre-market clinical trials. This data helps assess the device’s long-term safety and performance and may be used to update instructions for use or labeling.

Post-Market Safety Studies

In some cases, post-market studies may be conducted to further evaluate the device’s safety and effectiveness in specific patient populations or under particular conditions of use. These studies provide additional evidence and can help refine the device’s indications, contraindications, or usage guidelines.

Let WuXi AppTec Help You Through the Medical Device Development Process

Medical device development is a long process with a lot of steps. But, it doesn’t have to be overwhelming. Working with an experienced Class II medical device manufacturer can take the stress off your plate. At WuXi AppTec, we have more than 20 years of experience creating high-quality Class II medical devices. Whether you’re a small or large team, we can help you navigate the medical device development process from beginning to end.

Why should you work with us? We maintain industry certifications that hold us to the highest standards in medical device development. Our manufacturing facility in St. Paul, Minnesota 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, CBER, CDRH, and CDER. Additionally, we adhere to good manufacturing practices (GMP). These certifications allow us to develop high-quality medical devices and streamline the approval process.

While we don’t have an in-house design or regulatory team, we can help direct you to the right resources to ensure you get exactly what you need.  Our years of manufacturing and industry experience combined with trusted partners allow us to provide the assistance to accelerate the process.

Let’s Get Started

Want to hear more about what we can do for you? Reach out to us today.

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