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Testimonials

“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

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

Chelsea Chapin

KAT Medical

“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, Fides Maldonado 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 helpedus 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

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The Latest News

MEDIcept

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...

FDA Inspection? We Can Help You Relax.

Nothing can strike fear into the heart of a medical device manufacturer quite like an unexpected notice from the FDA. How you prepare for an FDA inspection? What is the process? What are they going to look for? Are they really that mean? After the inspection how do you respond to a 483 notice or worse what happens if you received a warning letter? How you perform during the inspection can make all the difference in the world between a quick resolution and a long expensive remediation program....
MEDIcept

Validating Medical Devices

One of the cornerstones of medical device manufacturing is the ability to efficiently and cost-effectively validate medical devices to ensure FDA compliance and to successfully and profitably bring medical products to market. Proper validation is a core requirement for any medical device manufacturer looking to achieve regulatory agency compliance and sell their products domestically and internationally. At MEDIcept, we understand that medical device testing is a rigorous and complex process...