Call Us Today at 508-231-8842        EMERGENCY

Regulatory Affairs

Our services include:

  • US Agent
  • FDA Establishment Registration and Medical Device Listing
  • Assistance with MDR and Vigilance reporting
  • Medical Device and Biologics Regulatory Support, including in vitro diagnostics
  • Troubleshoot and assist with stalled FDA applications
  • Labeling/advertising/promotional material assessment
  • Blood and Source Plasma Collection Center Regulatory Support
  • Assist with development or review of Clinical Study Protocols; Clinical Study Report Preparation
  • Preparation or review of:
  • US FDA: BLA, IND, PMA, 510(k), De Novo, IDE; 513(g), Pre-submission applications
  • Canada: Health Canada Medical Device and Medical Device Establishment License applications
  • EU: Technical Files, Design Dossiers, Clinical Evaluation Reports, IVD Performance Evaluation and Post-Market Follow-up documentation
  • Design and execution of Summative Usability Studies; Usability Study Report Preparation
  • Regulatory training
  • Regulatory Due Diligence

Commercializing medical products requires careful navigation through complex FDA and international regulations. Many companies fail to realize how challenging and expensive regulatory compliance can get without a thorough and effective regulatory strategy based on a strong understanding of the regulatory process.

All medical device companies must register with the FDA. If they sell products in the United States, they must list their products. MEDIcept helps companies through the bureaucratic FDA database system.

Regulatory Affairs, it all comes down to nuance and experience. As regulatory consultants, we have decades of hands-on regulatory strategy and implementation experience, successfully gaining regulatory clearance for over 175 medical devices. We have firsthand experience working with reviewers because some of our staff are former FDA and ISO submission reviewers.

If you are an international company exporting medical devices into the United States, you must have a US agent based in the United States to answer FDA and US Customs questions. MEDIcept serves as a US agent for international companies, answering questions and helping address such issues as US Customs seizures and FDA inspection notifications. MEDIcept can help you prepare for a FDA inspections and audits with a mock FDA inspection and mock FDA audit.

Obtaining an international CE mark requires the know-how to interpret the MDD and present information specific to each country’s requirements. We have written technical files for all classes of medical device and will help you prepare for your Notified Body meetings and audits.

Sign up to receive our Newsletters!

The Latest News

Artificial Intelligence: What you need to know about next-gen smart medical device compliance

Recent strides in artificial intelligence (AI) and machine learning technology is opening the door to the development of increasingly smart medical devices capable of turning big data and digital information into actionable insights for healthcare professionals. AI is having a significant impact on the evolution of smart devices and how healthcare will be delivered in the future. AI, coupled with machine learning, is calling into question what it means to approve a medical device capable of...

Mobile Medical Apps

In today’s wireless world, it seems everyone has a smartphone and it’s revolutionizing how services and information are presented and accessed. In the healthcare industry, this means rapid advances in telemedicine and the development of mobile medical apps (MMAs) which raise some unique concerns for compliance and challenges for regulation by the FDA and medical regulatory submissions. It is important to determine if your product is a regulated MMA or not a medical device. On May 17, 2019, the...
MEDIcept

Digital Health Innovation and Regulatory Compliance

Advances in digital health technology and innovation are picking up speed as wireless communications continue to evolve and become incorporated in growing numbers of devices, systems, and networks. The cloud, , are only fueling the demand for wireless and cloud-based integration of medical devices, which promises to improve the delivery of healthcare, often at reduced costs. Telemedicine, wearable devices, artificial intelligence (AI), and remote diagnostic and monitoring systems are just some...