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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

FDA Updates Special 510(k) Guidance

FDA’s Special 510(k) submission process has been around for years as an expedited method to demonstrate that the device to be marketed is at least as safe and effective (i.e., substantially equivalent), to a legally-marketed device not subject to the Premarket Approval (PMA) process. In September 2019, a modified version of this program was published to create a streamlined review of technological changes made to a manufacturer’s own cleared device which leveraged design control requirements....

Metal Implants: FDA’s November, 2019 Immunology Devices Panel Meeting

The Immunology Devices Panel of the FDA’s Medical Device Advisory Committee met in November to discuss the topic of immunological responses to metal-containing products regulated as medical devices. The panel focused on metal-containing implants as well as dental amalgam. Recent post-market issues with some metal-on-metal orthopedic implants and gynecological metal-containing implants have raised questions about the potential for some patients to develop unexpected or heightened biological...

Quality Systems in Motion, Inc. (QSIM) is now part of MEDIcept Inc.

For Immediate Release Ashland, MA: MEDIcept Inc, an international quality, regulatory, and clinical consulting firm focused on medical device and in-vitro diagnostics (IVD), and QSIM, a US-based privately held consulting firm specializing in medical device/biotechnology, announces the merger of the two companies. QSIM, under the direction of Brian Markham, President, specialized in providing leadership and resources for organizations undergoing significant quality system change due to...