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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.

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The Latest News

What You Need to Know About GDPR

What You Need to Know About GDPR

If you’re a medical device manufacturer planning do to business with the European Union you need to know about the regulatory change that took place in May 2018 that could have operational process and financial implications for your business. The new General Data Protection Regulation (GDPR) contains both existing and new data privacy requirements that, if not met, can result in significant fines of up to 20 million Euro or four percent of annual turnover. Maintaining compliance is required of...
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Are You a Start-Up? We Can Help.

Last year the US medical device industry achieved over $150 billion in sales, making it one of the most lucrative industries in the country. However, launching a medical device start-up in this highly regulated industry can be fraught with challenges. Medical product start-ups need to minimize regulatory and compliance risk to attract early-stage investors and save money. To complicate matters even more, recent changes in FDA regulations make it more important than ever to limit potential...
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Covering All Angles of Quality Assurance

Every responsible medical device manufacturer is aware that the FDA requires them to establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications – a protocol known as current good manufacturing practices (CGMP). These requirements were written into the original regulation issued back in 1978, which was revised, starting in 1990, into a broader and more consistent quality system (QS) regulation that is in effect today. Of...