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.

Biotechnology

Clinical Trials

Medical Devices

MEDIcept Inc.

MEDIcept Inc.'s headquarters in Boston, United States

F. David Rothkopf

Jason Gromek

Bob Silva

Lelia Adelina Paunescu

Carolyn Russell

Sean Yohey

Don Flitton

Brian Markham

Henry Hidalgo

Danielle Short

Ryan Satterly

Mary Huebner

Gregg V.

The Clinical and Medical Operations team at MEDIcept Inc. oversees the planning, execution, and management of clinical trials to ensure they meet regulatory standards and client objectives. This team is responsible for developing clinical strategies, managing trial logistics, monitoring compliance in the field, and producing comprehensive medical documentation. Leveraging their extensive industry experience, the team ensures clients' clinical projects are completed efficiently and effectively, thereby reducing time-to-market and business risks.

Clinical and Medical Operations

The Leadership Team at MEDIcept Inc. is responsible for guiding the strategic direction and overall operations of the company. This team, comprising the President, Executive Vice President of Sales and Operations, Partner and VP of Clinical Affairs, and Vice President of Commercialization, collaborates to ensure that MEDIcept delivers proven, trusted, and cost-effective compliance consulting solutions. They oversee regulatory strategy development, quality system management, clinical trial establishment, and business commercialization efforts, ensuring the company meets client needs efficiently while navigating complex regulatory pathways.

Leadership Team

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

MEDIcept Inc.

Org chart

Teams

Clinical and Medical Operations

Leadership Team

Quality Management

Offices

MEDIcept Inc.

Org chart

Teams

Clinical and Medical Operations

Leadership Team

Quality Management

Offices

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