We provide everything from full-service domestic and international submissions, to daily regulatory tasks. Our passion is partnering with teams to provide the best regulatory service at the most cost-effective price. Our team is comprised exclusively of medical device engineers, which provides us the ability to interface with product development teams at a depth that can help them understand and efficiently work within the given regulatory frameworks and guidance. We interact with the FDA and numerous other regulatory agencies on a weekly basis, making our expertise current and relevant. Our expertise, experience, and innovation are aligned and harnessed to deliver excellent guidance to your product development team in the most cost-efficient manner.
FDA Submissions (510k, De Novas, PMAs, etc.)
Our experts can develop your strategy, lead your product development team, advise and assist with your testing, write the submission, and interact with the regulatory agency at all levels to help provide the fastest clearances possible.Get in touch
Do you need help understanding the regulatory pathway for your idea or product? Our experts can provide guidance. Our team of Biomedical Engineers has years of experience classifying and gaining clearances around the world for thousands of devices and products.Get in touch
Investigational Device Exemptions (IDEs)
Clinical research studies can be a key first step in a product development and clearance pathway. Let our experts help you with the regulatory plan, the protocol development, pre-IDE meetings with the FDA and IDE submission, follow-up, and completion. We can help at any stage or any step.Get in touch
FDA Registration and Listing
Not sure if you need to register with the FDA? Not sure how to register? It is not you; the FDA registration process is difficult to understand and the actual process is not clear or easy to do. Lucky for you, we have done plenty, so we would be happy to help you understand if you need to register and how to register. We will even be happy to register your company with the FDA at no cost.Get in touch
Medical Device Reporting (MDRs)
Do you understand the process? Are you registered with the FDA? Do you need help understanding or executing the review of complaints? If you answered yes to any of these questions, let us help. We have experts that understand both the engineering side of the product, as well as the regulatory aspects of the situation. We can provide expert advice and/or MDR reporting if needed. We can also address worldwide reporting too.Get in touch
Did you just go through an FDA audit, and now you have a pile of 483’s? Do you know what to do? Do you need some extra qualified hands to get them addressed? Or do you just have questions and need some advice? Call us. We can handle all 483 questions and FDA interactions.Get in touch
International Medical Device Submissions
Wondering what the requirements for marketing your device in Thailand? Or does Canada look like it could be a great next step for your company? We can help you tailor an international regulatory strategy as well as execute the plan.Get in touch
European Medical Device Regulations/CE Mark (EuMDR)
The changes in European Union were both of a regulatory nature, however, it is also a significant cultural change in the way the process works. If you are looking towards European expansion, we would be happy to help.Get in touch
Clinical Evaluation Reports (CERs)
As part of the new EuMDR changes, clinical evaluation reports have taken on an even more prominent role. Do you have Class I products that now need CERs? Do you have products with outdated CERs? Our team is here to assist.Get in touch
Have a question?
Should My Class I Device Have Design Controls?
Design controls are a set of processes and procedures that are used to ensure the safety and effectiveness…
When Do You Need an IRB?
IRB or Institutional Review Board is an FDA-approved group that’s responsible for monitoring any biomedical research or study…
Outlining the Design Control Process of Medical Devices
In the medical industry, Design Controls facilitate the structural and developmental process of medical devices, particularly Class II…