MEDIcept strives to provide our clients with proven, trusted, and cost-effective solutions. 

We are an international medical device, IVD, combination product, and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost-effective Regulatory, Quality, Clinical, Auditing, and Educational services. Our experienced team of former FDA, Notified Body, 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.

MEDIcept will help you navigate the complex FDA and international regulatory pathways, reduce business risk, and decrease time-to-market while maximizing your potential for success. Every client and every issue is unique. We customize our solutions to fit your needs. With a retention rate of over 90%, we can promise that you will benefit from working with us.

Clinical Trials

Biotechnology

Medical Devices

MEDIcept Inc.

F. David Rothkopf

Jason Gromek

Bob Silva

Lelia Adelina Paunescu

John Z.

Carolyn Russell

Sean Yohey

The Quality Management team at MEDIcept Inc. is responsible for developing, implementing, and overseeing quality management systems (QMS) to ensure compliance with regulatory requirements for medical devices, IVDs, combination products, and biotechnologies. This team works closely with clients to create and remediate quality systems, ensuring that all products meet stringent FDA and international standards, thus minimizing business risks and accelerating time-to-market.

Quality Management

Clinical and Medical Operations

Leadership Team

Quality Management

About

Team members

Other teams at MEDIcept Inc.

Clinical and Medical Operations

Leadership Team