FDA Compliance Services for the Medical Device Industry
FDA Regulatory Strategy
Several organizations are of the belief that there is no place for meticulously planned FDA regulatory strategies when it comes to getting their FDA license and maintaining their FDA compliance. However, after being in the industry for years, we have come to understand that an interplay between the product development process and FDA submission process actually shapes them. Because of this, we at VZG can help you with the following:
Maximizing your product revenues by giving you opportunities to sell your product even when the FDA is still in the process of reviewing your files;
Minimizing the time it takes for you to submit the required documents by outlining the steps necessary for you to prepare your submission correctly;
Minimizing your expenses in the submission process by laying out a specific roadmap that helps you identify the necessary steps for the proper submission of your documents, reduce or eradicate clinical trial mistakes, and minimize errors in the implementation of a quality system; and
Optimizing your competitive situation by assessing how your submission and company structure can affect your suppliers, customers, and competitors.
Clinical Trial Management Services
VZG offers clinical trial management services that help you get ready for market approval. From developing the clinical protocols, setting up an and interacting with the Institutional Review Board (IRB), and submitting the Investigational Device Exception (IDE) to monitoring clinical trials, gathering and analyzing data, and managing the entire project, we will work closely with you so as to help you obtain FDA’s approval quickly and inexpensively.
There are premarket documents that are required to be submitted before a medical device company can successfully market in the U.S.
A 510(k) premarket notification is an application that is required from domestic manufacturers, foreign manufacturers, and specification developers, among others, to confirm the safety and efficacy of a device vis-a-vis its predicate device. A premarket approval (PMA) is an application that is required for certain medical devices where there exists no substantially equivalent product while a drug master file (DMF) is a file that includes the clinical, safety, and technical information about the components of a medical device.
While these documents may seem straightforward, many companies that are looking to market their medical device in the U.S. have encountered unforeseeable difficulties when it comes to preparing and submitting these documents. Hence, VZG helps these firms to prepare and submit these required premarket documents to the U.S. FDA in order to help these companies get approved. Our consultants have in-depth knowledge on how to prepare and submit your required documents.
Here are just some of the problems that may require you to ask for assistance from experienced consultants like VZG:
Advertising material that does not match its intended use
Contradictory, highly technical, poorly written, or unclear cover letters for 510(k) submission
Incorrect device classification
Incorrect device comparisons
Little understanding of the requirements for clinical trial
Poor presentation of the data for clinical trials
FDA Quality System Regulation Services
Guaranteeing the compliance of your organization with all FDA quality system requirements is vital. However, because the FDA compliance process differs greatly for every company, it is important that you put careful thought on these kinds of decisions and their planning. Otherwise, they will affect the speed and cost of your company’s implementation, as well as your potential savings and the speed it will take for you to get approved by the FDA.
Quality System Implementation Services
At VZG, we can help you prepare and implement the entire quality system for FDA Quality System Regulation (QSR) or Current Good Manufacturing Practices (cGMP) compliance. From quality manual and quality procedures to work instructions, product quality plans, and production-level quality records, we can assist you in implementing a quality system that is customized for your operations.
QSR/cGMP Audit Services
As a recognized FDA expert, VZG can provide you with a mock FDA audit that is similar to what you would expect to receive from the FDA and is performed in a similar manner to an FDA audit. This FDA audit of your company’s operations may help you determine the degree of your compliance with the FDA cGMP so that you can test your quality system and take the appropriate measures for corrective actions.
We provide FDA cGMP in-house employee and internal auditor training programs that have been customized to your products and operations. Our training services cover all aspects of FDA quality system requirements and regulatory requirements, including cGMP compliance, dealing with FDA inspections, FDA strategic planning, and preparing replies to Warning Letters, among others.
FDA Validation Guidelines
As an organization that has successfully navigated through a number of FDA inspections both locally and internationally, we know the challenges involved in dealing with the FDA, especially during an inspection that could prevent product commercialization. We can also assist you if you would rather expedite the inspection.
Most regulatory authorities across the globe require medical device companies to conduct a risk analysis of the device, from its entire life cycle to post-marketing design changes. For more information, please visit our Risk Analysis page.