Your Perfect Solution For FDA Medical Device Consultant Requirements Is Here

 Are you worried that passing FDA regulations for your medical device will slow your time to market and cause major headaches for your team? Speed ​​to market is a huge competitive advantage for companies in the equipment manufacturing industry. Avoidable delays can result in physical and indirect costs to your business, including loss of competitive advantage or regulatory penalties. While the best eQMS (Essential Quality Management Systems) and knowledge of regulatory requirements can help you achieve FDA cGMP compliance, your organization can also opt for expert help. Relying on a consultant to guide you through the process can make things easier and give you peace of mind.

As the U.S. Food and Drug Administration's IVD and medical device review processes become more complex, working with an experienced FDA medical device consultant can make a significant difference in your marketing licensing and compliance efforts. Smart companies hire FDA consultants before they get stuck to make sure they're setting up their quality management system (QMS) correctly. 

Organizations often hire FDA consultants when faced with FDA action or challenges with product submissions because existing QMS systems are inadequate. It often takes an independent eye to see things clearly and make real changes. 

Our Approach

Unmatched consulting experience

We identify and hire only top-quality consultants with in-depth industry knowledge to provide the most relevant and comprehensive advice to our clients.

The system and Process Are Up-to-date

We have well-defined systems (e.g. manuals, training programs, technical records) and processes that are continuously improved and updated in the ever-changing regulatory environment.

Participate in the development of regulations

We stay ahead of policy by participating in the development of regulations.

FDA Regulatory Submissions and Registrations include

510(k) Submissions to FDA, Emergency Use Authorizations for COVID-19, Pre-subs, Establishment Registrations, Device Listings, UDI, International Registrations (Latin America, Asia, Eastern Europe, and the Middle East), EU CE Marking and Tech File/Design Dossier Creation and Maintenance. Clinical Evaluation Report (CER).

Our Experience with medical devices

We work with all types of medical devices and are familiar with the regulatory submissions Toolkit process and tools. We welcome all kinds of medical devices that guide you through the administration process smoothly with step by step process. Contact us for a free consultation.

Our Process And Strategy

We are de facto strategy developers, information hunters, lifelong learners, and connected team players. We are dedicated to improving existing processes for maximum productivity, taking a lean approach to reduce costs. We believe in finding the strongest regulatory, quality, and compliance solutions and strive to find the least burdensome approach within the right limits for our customers. to help answer your questions and guide you through the complex regulatory and quality space. 

The ethics and intrinsic values ​​instilled within us are of the highest caliber and we believe in dialogue, mutual contribution, and respect for keeping relationships intact in the event of disagreement. Since we have been in this industry for most of our careers, we are as confident in our ability to help you as we are with others. We know your challenges and provide the best solutions for the same.

The Thomas Regulatory Resolutions understands the urgency of developing products during pandemics and natural disasters. Our Emergency Use Authorization team has experience in medical products and related authorities, product development, and quality compliance. That's why we provide perfect FDA COVID-19 Coronavirus SARS-COV-2 Consultant services. We'll take your product quality, compliance, and registration systems to the next level to increase efficiency and reduce time-to-market while implementing best practices. The first consultation is always free! Contact us now!

Conclusion

Thomas Regulatory Resolutions is a leader in providing consulting services to the healthcare industry worldwide. We have extensive expertise in helping medical device, pharmaceutical, biotech, and food device companies comply with US, and European regulations. Thomas Regulatory Resolutions is a full-service FDA consulting firm providing the best medical device consultant services. Our consulting capabilities cover all regulatory and compliance aspects of combined product and device development. We have experience with medical devices in all classes covering a wide range of indications. We are highly qualified to assist you in all stages of product development, throughout the approval process, and post-marketing requirements.