FDA Compliance and Medical Device Consulting from the Experts

Three decades of experience providing trusted solutions and rapid response to the medical device industry.

MEDIcept is uniquely qualified  to help you navigate complex regulatory pathways, reducing your business risk and time-to-market, while maximizing your potential for success.

About Us Emergency Services

Quality Management System

Medical Device Quality Management Systems

Quality System Audits

FDA 483, Warning Letter, Consent Decree

QMS Remediation

Interim Quality Professionals

Post-Market Surveillance

Training and Education

Regulatory

Global Regulatory Strategy and Registration

Regulatory Agency Communication and Meetings

US Regulatory Submission: Pre-sub, 513(g), 510(k), De Novo, PMA

EU-MDR/IVDR Technical Documentation

Clinical Evaluation Report

Regulatory Due Diligence

Interim Regulatory Professionals

Clinical Research Organization

Clinical Strategy and Submissions

Trial Start-Up and Management

Site Management and Monitoring

Data Management & Biostatistics

Safety Management

Medical Writing

Decentralized Clinical Trials

Vendor Management and Clinical System Solutions

Clinical Quality Audits

Medical Affairs

Quality Engineering

Risk Management ISO 14971

DHF Remediation and Development

Medical Device Software Compliance IEC 62304

Usability IEC 62366

Process Validation

Cybersecurity

IEC 60601

Medical Device Reimbursement

Health Economic Analysis

Reimbursement Strategy Roadmap

Comprehensive Landscape Assessment

Healthcare Compliance

Fractional Compliance Officer

Compliance Officer Support

Fraud, Waste, and Abuse Prevention

HIPAA Privacy Compliance

Compliance Training

Gap Analysis

Ongoing Monitoring

I need help NOW!

Have you received an FDA 483 notice or a warning letter? Are you struggling to meet new EU MDR or EU IVDR regulations? MEDIcept can help you respond quickly and effectively to help prevent a difficult situation from turning critical.

We Can Help

Need FDA or EU MDR/IVDR audit assistance?

Don't do it alone. Our deep, firsthand experience with FDA and EU MDR/IVDR audits can help you minimize risk and business disruption.

IVDR Transition Updates

Are you a start-up?

We’ve helped a wide range of start-ups develop effective regulatory strategies to obtain FDA and EU MDR clearances. We’ll work with you to develop the right domestic or global regulatory strategy for your business to help ensure compliance and product approvals.

Get Started

What You Can Expect

For Over 25 Years

Our medical device 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. We have 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

We recognize that every client and issue are unique. MEDIcept customizes our solutions to fit your business and products.

Successful Approach

With a retention rate of over 90%, our clients trust us and we can promise that you will benefit from working with us through both time and cost savings.

EPA Limits ETO Emissions

Adelina, Your courtesy, diligence and professionalism are outstanding. You have helped us greatly navigate the world of regulatory affairs with excellent patience and caring attitude. Your knowledge and expertise along with your experience in technical and scientific issues gives us the confidence that we are in the best of hands when you look after our projects. Your level of detail and attention to our needs is truly a blessing.

On behalf of Orthoworld I want to congratulate you for your work and hope you will always be our most trusted guardian angel.

Dr. Anthony Viazis – President, Orthoworld

“Thank you, I am confident your assistance will go a long ways with the PV team as we prepare for the inevitable FDA audit. I now consider your organization part of the PV team and believe your collaboration will be helpful. I am pleased and appreciative of yours and Inez work.”

Dr. Errol Singh – President, PercuVision

“Thank you very much for your kind help concerning this supplier audit. Thanks to your great help, our audit finished successfully.”

Dr. Kenji Hosoda – General Manager, Teijin Pharma Limited

“No 483s. You guys are the best! Thanks for your help preparing us for the inspection.”

Paul, Fisher & Paykel Healthcare

“Your help and guidance is a major contributor and driver for our success; in one week a perfect FDA inspection and a 510(k) clearance – thank you.”

Tally E. – President, QCore

“Your help was greatly appreciated this past week. Dr. Bondar is still singing your praises.”

Chelsea Chapin – KAT Medical

“Another quick clearance through FDA. Thanks for all your help. We’ll be back with more.”

President, Small spinal implant company

“MEDIcept’s engineers are some of the best I have ever worked with, absolutely world class.”

Allen (Jack) Latham – Founder, Haemonetics

“Medicept engineers are able to match the procedures that the customer is looking for perfectly on target, to the needs of the facility, plus more with just the fine details.”

Jocelyn E. – LHI Technology, USA

“Thank you very much. With your help with the FDA audit, it was a success.”

Andrey Vyshedskiy, Ph.D. – Chief Technology Officer, Stethographics

“MEDIcept was effective at helping refine my thinking regarding new methods for RCR and helped prepare the new invention for commercialization. Very efficient communication and offered relevant feedback throughout the process. MEDIcept is a valuable resource for any surgeon-inventor.”

Dr. Phil Davidson – Tampa Bay Orthopedic Specialists and the University of South Florida

“MEDIcept has been easy for all to work with, they know a lot about out company and everyone actually enjoyed working with them. Their consultant conducts herself as a professional, she added value to many projects and communicates with all the team members. She has been a big assistance to me and my team and I look forward to getting this project completed and then looking ahead to the next.”

Paul Caracciolo – Director of Quality Assurance, Putnam Plastics

“Thank you, Sharyn has been an invaluable resource to us. We very much appreciate her being available for our meetings and her quick response to all requests.”

President, Pre-revenue IVD Company

“MEDIcept is doing a great job, as we knew you would; all our needs are being met and exceeded.”

John Slamin – Conformis

“I just wanted to thank you for getting us through this FDA inspection; you have helped us raise the bar in a very short time! Your help with the FDA audit was invaluable.”

Tais Clausen – 3 Shape A/S

“Medicept is an outstanding quality consulting firm which never misses a beat on matching the client’s Quality needs with the daily, regulating and mandated FDA and ISO requirements.”

Jocelyn E. – LHI Technology, USA

“When there is a need for future help I will reach out to Todd who by the way is excellent in expertise and to work with”

R. Von Jako – GE HealthCare

“The MEDIcept Team Consultants have been a big help to us for supporting our risk management activities to comply with EU MDR requirements for medical devices. They have demonstrated technical and compliance expertise, been responsive for time sensitive projects, and conducted themselves in a collaborative and professional manner.”

Christa Daukshus – Manager of Design Assurance, B. Braun Medical Inc.

“In working with MEDIcept over the last 20+ years, Dave and his team have been able to provide strategy, direction and answers whether it be Regulatory, Quality System or personnel transition in a time frame that met our business needs. Their vast industry knowledge and ability to establish immediate working relationships have left long lasting positive impressions with my teams.”

Mike, Corindus

“MEDIcept, thanks so much for all your efforts, hard work, and good company. Without your management in the back room the FDA inspection would not have gone so well.”

Carl Y., Dir of Manufacturing Business Group Olympus

“I have worked had the absolute pleasure of working with David Rothkopf and Medicept for over 13 years. Looking back I know that I couldn’t find a stronger individual to work with OrthoCor Medical reimbursement. Not only was David uniquely experienced our field of Pulsed Electromagnetic Field therapy but his relation with the FDA was crucial in our receiving multiple Class III clearances from the FDA. We initial met David as a Start-Up so the fact that he was an entrepreneur greatly strengthened our relationship ad our working together. Mr. Rothkopf and his team were essential to the success of OrthoCor. Not only do I consider David and Medicept the best regulatory and clinical consulting group in the country but I now consider David a close friend.”

John D., OrthoCor Medical

“I used Susan Reilly and her team at MEDIcept from the inception of my medical device startup through the integration of its acquisition by a larger company. She navigated us from the development of a quality system for a fully virtual company (i.e. no employees) through obtaining ISO 13485, the CE Mark, several FDA product clearances, and many flavors of audits – all in less than five years. It would impossible to overstate the value she and MEDIcept brought to our company. I highly recommend her and her team for their competence, knowledge, and professionalism, all while being priced fairly and a pleasure to work with. I will not look elsewhere the next time I have a medical device quality or regulatory need. “

Nancy Confrey – CEO, Health Beacons, Inc.

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