Medical Devices in a Modern World
Medical devices are present in almost all aspects of life; they are everywhere. As technology continues to improve and drive the world we live in, medical devices and their associated technologies are evolving. Although these developing technologies have led to significant advancements in modern medicine, they have also made it increasingly more challenging from a regulatory perspective.
That is where we enter the equation – ProPharma Group is here to help you with all matters concerning the regulation and compliance of your medical device or combination product.
ProPharma Group’s Comprehensive Medical Device Consulting Services
ProPharma Group is a full-service FDA consulting firm that provides an all-inclusive medical device service offering. Our 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.
We are highly qualified to assist you during all product development phases, through the approval process, and with post-marketing requirements. Some of our medical device consulting capabilities include:
Medical Device Regulatory Strategies
It is essential to have a strategic and well-thought-out plan when preparing to approach your medical device’s FDA approval. Each interaction with the Agency should be carefully and tactically organized to maximize the information gained at each step in the process. A regulatory strategy provides the road map that you need.
Each company and product are unique. Accordingly, the journey taken to obtain FDA approval 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.
Find out more about Regulatory Strategies.
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 Group has the experience, knowledge, and expertise to ensure your FDA Meeting is planned and conducted as seamlessly as possible.
ProPharma Group’s medical device-related FDA meeting services include:
- Pre-Submission Meetings
- Submission Issue Meetings
- Informational Meetings
- PMA Day 100 Meetings
- Medical Device Advisory Committee Meetings
Find out more about FDA Meetings.
Medical Device 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 Group can help you determine your device’s classification and assist in preparing and submitting the appropriate application(s).
ProPharma Group’s medical device submission services include:
- Investigational Device Exemption (IDE) Submissions
- 513(g) Request for Information Submissions
- 510(k) (Premarket Approval) Submissions
- Premarket Approval (PMA) Submissions
- De Novo Request Submissions
- Humanitarian Use Designation (HUD)/Humanitarian Device Exemption (HDE) Submissions
Find out more about FDA Submissions.
Medical Device Registration & 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 is 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, completing each step as smooth and painless as possible.
Medical Device Quality Management & 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 Group takes a holistic approach to quality and compliance, leveraging our expertise in 21 CFR 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 & GMP Audits
- Quality Systems Design & Implementation
- Assess Quality System Regulations (QSR) Compliance
- Software Validation
- Support for ISO certification & Compliance
- Product Development Planning & Design
- Remediation services after receiving an FDA Form 483, Warning Letter, or Consent Decree
Find out more about Quality Management & Compliance.
Medical Device Risk Management & 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 Group can help you do exactly that. Using the standards laid out in ISO 14971, we can help you determine whether your medical device’s benefits outweigh any potential risks and help you present the data to the FDA.
ProPharma Group: 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 the past 37 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.
ProPharma Group is an experienced medical device consultancy, contact us today to learn more about our qualifications and services regarding medical devices and combination products.