Trusted Solutions, Rapid Response
Expertise you can trust for the success of your medical products.MEDIcept strives to provide our clients with proven, trusted, and cost-effective solutions. With decades of combined experience in the global medical device industry, we are uniquely qualified to help you navigate complex regulatory pathways, reducing your business risk and time-to-market, while maximizing your potential for success.
I need help NOW!
Have you received a 483 notice or a warning letter? Is your ISO certificate or CE Mark in jeopardy? We can help you respond quickly and effectively to prevent a difficult situation from getting worse.
Are you facing an FDA inspection?
Are you facing an FDA inspection or ISO audit? Don’t go it alone. Our knowledgeable team with first-hand experience will help you prepare with confidence.
Are you a start-up?
Starting a new company in the highly regulated medical industry is no easy feat. We can help you at every step of the journey – from product innovation and regulatory strategy, to design controls and risk management, through clinical trials, submissions, and quality management systems.
What you can expect
For Over 25 Years
Our unique consulting practice has assisted thousands of companies of all sizes with cost-effective Regulatory, Quality, and Clinical services.
Worldwide
MEDIcept is an international medical device and IVD compliance consulting firm with active clients on 6 continents. MEDIcept has a global clinical team supporting all clinical trials and post-market studies.
Experienced Team
Our experienced team of former FDA, ISO, and industry experts will work with you to efficiently develop or remediate a quality system, create a regulatory strategy, or establish a clinical trial, to meet your specific needs.
Clear Navigators
MEDIcept will help you navigate the complex FDA and international regulatory pathways, reduce business risk, and decrease time-to-market while also maximizing the potential for success in the market.
Customized Approach
Every client and every issue are unique. We customize our solutions to fit your needs.
Successful Approach
With a retention rate of over 90%, our clients trust us, we can promise that you will benefit from working with us.
