Call Us Today at 508-231-8842        EMERGENCY

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

Sign up to receive our Newsletters!

The Latest News

We are state-of-the-art in the validation process

US Food and Drug Administration (FDA) and international regulatory standards continue to evolve and become more stringent as medical devices become more complex in design, functionality, and technological integration. This makes the process of medical device validation and verification even more important—not only to comply with regulations, but also to aid in the design of the highest-quality components and the production process. The desired result is better repeatability, fewer mistakes,...

MDSAP: Cybersecurity and the single audit process program

For those who may not be entirely familiar with the Medical Device Single Audit Program (MDSAP), this initiative is intended to allow auditors from MDSAP-recognized Auditing Organizations (AOs) to conduct a single audit of a medical device manufacturer’s quality management system that will satisfy the requirements of the medical device regulatory authorities participating in the MDSAP program. The countries currently participating in the program include the United States, Canada, Japan,...

Medical Device Single Audit Program: What you need to know, Pt. I

Both the medical device industry and international regulators have witnessed the growing need for a standardized, worldwide approach to auditing and monitoring medical device manufacturing. A single, comprehensive process would reduce costs and speed time to market. With that goal in mind, the International Medical Device Regulators Forum (IMDRF) began work several years ago to create a program framework that would enable the conduct of a single regulatory audit of a medical device...