Expert Guidance for Device and Diagnostics Development
From concept development through Food and Drug Administration (FDA) and European Union (EU) approval, our team of specialists is highly qualified to assist you in all aspects of medical device and diagnostic regulation throughout the product lifecycle. If you are in process of developing an FDA or EMA regulated product, our experienced team of specialists can help you achieve successful regulatory outcomes in the most expeditious way possible to help you realize the value of those outcomes sooner.
Medical Device & Diagnostics
The path for medical devices and diagnostics trials is different from drug development, which is why we have a dedicated team of experts who focus solely on supporting our device and diagnostics clients. Our experts understand what it takes to get these products to market and help design efficient and compliant trials to help meet your goals.
We help our clients navigate the regulatory challenges in both the US and EU associated with devices and diagnostics.
medical device & diagnostics
In Vitro Diagnostics (IVD)
In vitro diagnostics (IVD) products are medical devices that are intended for use in the diagnosis of disease or other medical conditions and assessing the current state of patient health. This unique subset of medical device includes reagents, instruments, software, and associated components that often work together as a system to achieve the design intent. ProPharma has expertise in the specific challenges that IVD manufacturers face in integrating the laboratory sciences with the engineering aspects of physical devices and instrumentation. We understand the entire IVD product lifecycle and can guide our clients through design and commercialization, manufacturing, and post market surveillance and reporting.
We have experience in the following IVD areas:
- Molecular Diagnostics
- Immunoassays
- Companion Diagnostics
- Point of Care Testing
- At-Home/Self Testing
In addition to a full suite of quality solutions, we support our clients with regulatory strategy and submission capabilities for the US and international markets. We also provide gap assessments and preparation services for transition from EU IVDD to IVDR.
Medical Device Product Development & Consulting
Our team of seasoned experts assist in all matters concerning the regulation and compliance of your medical device or combination product.. At each step in the development of your medical device, you will gain new information and data that will construct and change the steps that follow. As this happens, your regulatory strategy will transform as well. We work with you to integrate any new information into your overall plan, even if we didn’t develop the initial strategy. We will audit and adjust your regulatory strategy to optimize the pathway to approval for your medical device.
Medical Device Development Process & Regulations Overview
Before diving into our services, it’s important to have a basic understanding of the medical device development process. The FDA lists five stages in this process, with the purpose of ensuring design control so products are effective and safe.
The FDA’s stages in the medical device development process include:
- Phase I: Initiation Opportunity and Risk Analysis
- Phase II: Formulation Concept and Feasibility
- Phase III: Design and Development
- Phase IV: Final Validation and Product Launch Preparation
- Phase V: Product Launch and Post Launch Assessment
Furthermore, the FDA notes the following regulatory requirements for medical devices:
- Establishment registration
- Medical Device Listing
- Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA)
- Investigational Device Exemption (IDE) for clinical studies
- Quality System (QS) regulation
- Labeling requirements
- Medical Device Reporting (MDR)
Medical Device Consulting
ProPharma has a full range consulting capabilities across the US and EU , including an all-inclusive medical device consulting service offering. Our medical device consulting capabilities include all regulatory and compliance aspects of device and combination product development. We have experience with medical devices across all classes spanning a diverse range of indications. Our emphasis on science, coupled with the technical expertise of our medical device experts, allows us to effectively communicate with the FDA on their wavelength in support of your product.
Medical Device Regulatory Strategies
It is essential to have a strategic and well-thought-out plan when preparing to approach the FDA seeking approval of your medical device. Each interaction with the Agency should be carefully and tactically organized to maximize the information gained at each step in the medical device development process. A regulatory strategy provides the roadmap that you need.
Each company and product are unique. Accordingly, the journey taken to obtain FDA approval for your medical device will also be unique. We understand this and develop customized regulatory strategies for every company and every product, focusing on each client’s individual needs.
At each step in the development of your medical device, you will gain new information and data that will construct and change the steps that follow. As this happens, your regulatory strategy will transform as well. When this happens, we will work with you to integrate any new information into your overall plan, even if we didn’t develop the initial strategy. We will audit and adjust your regulatory strategy to optimize the pathway to approval for your medical device.
Medical Device FDA Meetings
The goal of any FDA meeting is to get answers to critical questions and gain insight into the Agency’s expectations. To achieve these goals, the meeting must be meticulously planned and executed impeccably, leaving the FDA with the best impression of both your medical device and your company. Making all of the pieces fit together requires the knowledge and experience of an expert. That is where we come into play. ProPharma has the experience, knowledge, and expertise to ensure your FDA meeting is planned and conducted as seamlessly as possible.
ProPharma’s medical device-related FDA meeting services include:
- Pre-Submission Meetings
- Submission Issue Meetings
- Informational Meetings
- Premarket Approval (PMA) Day 100 Meetings
- Medical Device Advisory Committee Meetings
FDA Submissions
Before a medical device can be sold in the United States, it must be evaluated and approved by the FDA’s Center for Devices and Radiological Health (CDRH). This approval is achieved by submitting the appropriate application(s) based on the device’s classification. Regulatory requirements vary based on whether your product is a Class I, II, or III medical device. ProPharma can help you determine your device’s classification and assist in the preparation and submission of the appropriate application(s).
ProPharma’s medical device submission services include:
- Investigational Device Exemption (IDE) Submissions
- 513(g) Request for Information Submissions
- 510(k) (Premarket Notification) Submissions
- Premarket Approval (PMA) Submissions
- De Novo Request Submissions
- Humanitarian Use Designation (HUD)/Humanitarian Device Exemption (HDE) Submissions
Medical Device FDA Registration and Listings
All facilities involved in the production and distribution of medical devices are required to register annually with the FDA. Most of the establishments subject to FDA’s registration requirements must also list the devices made in their facility and the activities performed on those devices.
Medical device registration and listing are critical to the regulation of medical devices. It provides the FDA with the location of all medical device establishments. It outlines all devices manufactured at those establishments, helping the Agency prepare for and respond to public health emergencies. However, determining whether you are required to register and list your facility and product(s) and then complete the registration and listing process can be very challenging. We can help you navigate this landscape, making each step as smooth and painless as possible.
Quality Management and Compliance
Like drugs and other FDA-regulated products, medical devices must also be compliant with the Agency’s Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards. Meeting these requirements is not always easy. ProPharma takes a holistic approach to quality and compliance, leveraging our expertise in 21CFR 820 and 21 CFR 4 to ensure your medical device or combination product is compliant with all applicable FDA regulations.
Our medical device-related quality and compliance services include:
- GCP and GMP Audits
- Quality Systems Design and Implementation
- Assess Quality System Regulations (QSR) Compliance
- Software Validation
- Support for ISO certification and Compliance
- Product Development Planning and Design
- Remediation services after receiving an FDA Form 483, Warning Letter, or Consent Decree
Medical Device Risk Management and Human Factors Engineering
Risk management is a critical component of medical device development and manufacturing. When working to minimize any use-related hazards and risks associated with your medical device, you must focus on how users interact with the device. ProPharma can help you do exactly that. Using the standards laid out in ISO 14971, we can help you determine whether the benefits of your medical device outweigh any potential risks and help you present the data to the FDA.
ProPharma: Medical Device Consulting Experts
Regardless of where you are in the development or approval of your medical device, we can help. We take a proprietary approach to the FDA, combining deep and broad scientific knowledge with extensive regulatory experience. This method has proven successful for decades, as we have assisted our clients in achieving FDA approvals for more than 30 years. Our emphasis on science, coupled with the technical expertise of our medical device experts, allows us to effectively communicate with the FDA on their wavelength in support of your product.
News & Insights
September 29, 2023
Navigating FDA User Fee Updates for Fiscal Year 2023
As the U.S. Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs...
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The Impact of a US Government Shutdown on the Food and Drug Administration
U.S. lawmakers are actively attempting to negotiate a deal to prevent a government shutdown on October 1, 2023. Along with many other government agencies, the ability of the Food and Drug...
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DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)
With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...
News & Insights
September 27, 2023
ProPharma Appoints Alena Hammond as Global Head of Clinical Operations
Raleigh, NC, September 27, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
September 13, 2023
ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI
Raleigh, NC, September 13, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
August 30, 2023
ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho
RALEIGH, NC, August 30, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
