Medical Device Manufacturing
Specialized Services to Accelerate Medical Device Innovation
Navigating the complexities of the medical device industry can be daunting, filled with risk mitigation and legal requirements at every level.
The Georgia Manufacturing Extension Partnership (GaMEP) at Georgia Tech offers specialized expertise to help you navigate the medical device industry. Our medical device project managers are experts in both medical device commercialization and manufacturing for medical devices. We help innovators, suppliers, and manufacturers successfully commercialize new medical devices and scale up their operations.
Services
Feasibility Assessment
Evaluate ideas or technologies for medical devices using the Phase Zero program, which analyzes market fit, user needs, technical feasibility, regulations, intellectual property, and reimbursement potential.
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Getting off to the right start in a new medical device’s commercialization process begins with appropriate use of scarce resources, risk identification and mitigation, and initiation of the legally required pathway. GaMEP’s medical device industry services team can help you navigate these factors and create a roadmap for success.
GaMEP will:
- Conduct a thorough market assessment, including potentially competitive technologies and reimbursement.
- Examine the IP landscape and freedom to operate to avoid infringement on existing patents or other intellectual property.
- Conduct a clinical/user needs assessment to ensure the device has sufficient demand potential and is not simply a solution in search of a problem.
- Evaluate regulatory pathways to determine risk classification, identify applicable product codes and potential predicate devices, and assess testing requirements.
- Facilitate technology development to assess technical viability, identify risks, and ensure alignment with regulatory, manufacturing, and user requirements.
By utilizing GaMEP’s feasibility assessment service, you will:
- Identify regulatory and market needs
- Validate user needs and technical fit
- Gain an understanding of IP, legal, and reimbursement risks
- Prepare to secure funding and develop the product
QMS Implementation, Maintenance and Audit Readiness
Implement and maintain a quality management system (QMS) that meets federal requirements and industry standards to mitigate risk and ensure patient safety and legal compliance.
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Medical devices are subject to stringent legal requirements for generating and maintaining a QMS and associated files. These requirements are outlined per the code of federal regulations and industry standards, i.e. 21 CFR 820 and ISO 13485, for risk mitigation to ensure patient safety and legal compliance at multiple levels.
Robust QMS practices ensure compliance, streamline regulatory processes, and mitigate risks in medical device development. We help researchers, faculty, and clinicians implement and maintain a comprehensive QMS and prepare for audits, while supporting ongoing quality management during the innovation, development, and commercialization lifecycle.
GaMEP will:
- Provide support in designing, building, and implementing a comprehensive QMS tailored to your product’s specific needs.
- Share insights into regulatory compliance strategies.
- Offer best practices for maintaining and optimizing your QMS.
- Prepare your team for successful quality audits.
By working with GaMEP for QMS implementation, you will:
- Gain a trusted advisor with deep industry knowledge
- Receive ongoing support
- Limit risk
- Achieve compliance
Product Realization
Begin the design and development process using a phased approach aligned with regulatory quality systems.
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The design and development process begins after a technology has completed Phase Zero evaluation and implemented a quality management system. GaMEP’s medical device team uses a legally compliant phased approach to medical device product realization.
GaMEP’s will facilitate the following phases:
- Phase 1: Planning – Define the scope of work, goals, requirements, and timelines, while identifying potential risks.
- Phase 2: Design and Development – Create formal product designs based on defined inputs, including user needs and feedback. Establish verification methods to confirm the design meets necessary requirements before the product enters a “no change zone,” or “design freeze.”
- Phase 3: Design Verification – Complete design testing and analysis to ensure that the product meets specified inputs and functions as intended.
- Phase 4: Design Validation – Ensure that the product fulfills its intended use in real-world scenarios, confirming that it delivers the desired outcome and performs safely.
- Phase 5: Design Transfer – Demonstrate readiness for manufacturing and commercialization by ensuring product design can be seamlessly transitioned into production, with appropriate manufacturing processes, quality control systems, and documentation.
By working with GaMEP on product realization activities, you will:
- De-risk your product
- Prepare for regulatory submission
- Create a design ready to transfer to manufacturing
- Be ready for commercial launch upon approval
Investigational Study Support
Prepare required documentation and reduce risk to meet legal standards for internal review boards (IRB) and FDA approval before conducting human trials, as mandated by 21 CFR 812.
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Most new medical devices will require human data from trials gated by IRBs and, depending on the risk, also the FDA. These entities require specific documentation and de-risking of a new device before they will approve its use in an investigational trial involving human patients.
GaMEP will:
- Conduct a determination or assessment of a device’s classification as significant risk (SR) or non-significant risk (NSR).
- Guide you through the requirements of NSR and SR investigational studies and develop the necessary documentation within a QMS.
By working with GaMEP, you will:
- Gain a trusted advisor
- De-risk your product
- Develop comprehensive documentation
Human Factors and Usability Engineering
Integrate human factors and usability engineering into your design process to enhance patient safety, reduce user errors, and support regulatory approval.
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Human factors engineering (HFE) is a critical component of medical device design, ensuring that products are intuitive, effective, and safe for end users, including patients and healthcare professionals. Compliance with ISO14971 (risk management and IEC 62366 (usability engineering mandates is essential to meet regulatory expectations and minimize use-related risks.
GaMEP will:
- Assess your device, providing suggestions to increase usability and minimize risk.
- Align design processes with FDA human factors guidance, ISO 14971, and IEC 62366.
- Conduct early-stage formative studies and validation testing to refine usability.
- Identify and mitigate use-related errors before market launch.
- Integrate usability engineering into design control processes.
By utlizing GaMEP’s human factors and usability engineering services, you will:
- Support regulatory approval
- Decrease risk
- Enhance usability
Design History
File Support
Establish and maintain a Design History File (DHF) or Medical Device File (MDF) to comply with U.S. regulations and international standards.
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Manufacturers of record for medical devices must establish and maintain a DHF or MDF to comply with U.S. regulations and international standards. These files serve as comprehensive records of design and development activities, ensuring traceability, regulatory compliance, and readiness for audits or market approvals.
A well-structured MDF not only fulfills regulatory obligations but also enhances product development efficiency, facilitates risk management, and streamlines design transfer to manufacturing.
GaMEP will:
- Guide the development, organization, and maintenance of DHFs or MDFs per regulatory requirements.
- Assess current DHF or MDF documentation practices to identify gaps and compliance risks.
- Help integrate design controls, risk management, and verification/validation documentation.
- Ensure alignment with FDA (21 CFR 820) and ISO 13485 standards for global market readiness.
- Support preparation for regulatory audits, submissions, and product lifecycle documentation management.
By utilizing GaMEP’s design history file services, you will:
- Ensure traceability
- Meet regulatory compliance
- Prepare for audits or market approvals
Packaging and Labeling
Implement effective packaging and labeling to meet safety and regulatory standards, protect the device, and ensure clear, compliant user instructions.
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Ensure product integrity, safety, and compliance with legal regulatory standards by creating effective packaging and labeling. Adhering to packaging and labeling requirements, such as those defined by 21 CFR 820, ISO 13485, and other regulatory bodies, is essential for medical device manufacturers to meet regulatory expectations and ensure patient safety.
Implementing robust packaging and labeling processes helps promote product functionality and accessibility, protects devices from contamination or damage, provides information for proper use, and ensures that all necessary warnings, instructions and regulatory marks are included.
GaMEP will:
- Assess current packaging and labeling practices to identify compliance gaps and opportunities for improvement.
- Guide the development and optimization of packaging designs to ensure product protection, safety, and ease of use.
- Assist in the creation of compliant labeling that meets 21 CFR 820, ISO 13485, and regulatory requirements.
- Support the integration of packaging and labeling processes with quality management systems.
By working with GaMEP’s medical device team on packaging and labeling, you will:
- Ensure compliance
- Protect product integrity
- Improve user safety and satisfaction
Medical Device Industry Training & Events
GaMEP hosts events and training courses designed specifically for medical device manufacturers. We also offer customized on-site training options. Contact your region manager for more information.
ISO 13485 Requirements- Quality Management Systems for Medical Devices
Learn the ISO 13485:2016 standard requirements and ways you can utilize a Quality Management System (QMS) to improve customer relationships, operations, and corporate culture.
Success Stories
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Ready to get started?
GaMEP divides the state into ten regions led by region managers, who live and work within the region they serve. Contact your Region Manager or fill out our Contact Us form and a GaMEP team member will get in touch with you shortly.