Regulatory

FDA Submissions (510K, De Novos, 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. ​ 510K DE NOVOs PMAs

Investigational Device Exemptions (IDE) 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.

Device Classification 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.

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. Good News, we have registered all kinds of companies. We are willing to register your company with the FDA with no additional costs from us.

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.

International Medical Device Submissions Wondering what the requirements for marketing your device in Thailand are? 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.

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 Do you have products with outdated CERs?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.

European Medical Device Regulations/CE Mark (EUMDR) The changes in the 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.

483’S 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.