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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

Two Premier Medical Device Firms Merge to Provide More Comprehensive Services

Ashland, MA: MEDIcept Inc, a leading international quality and regulatory consulting firm focused on medical device and in-vitro diagnostics (IVD), and Reilly & Associates, a US-based privately held consulting firm specializing in medical device/biotechnology, announces the merger of the two companies.The merger promotes the shared strategic goal of becoming a world-wide, leading quality and regulatory value-added service firm focusing on medical devices and medical technology....

How Can You Outsource Quality Assurance?

If you’re a medical device manufacturer – and especially a smaller one, such as a recent start-up – the real question might be “How can you NOT outsource quality assurance?” Smaller firms such as start-ups are especially vulnerable to issues surrounding quality assurance and quality system development. Hiring an experienced QA professional or quality engineer can cut deeply into limited funds, never mind actually getting a Quality Management System (QMS) up and running. For small or...
What You Need to Know About GDPR

What You Need to Know About GDPR

If you’re a medical device manufacturer planning do to business with the European Union you need to know about the regulatory change that took place in May 2018 that could have operational process and financial implications for your business. The new General Data Protection Regulation (GDPR) contains both existing and new data privacy requirements that, if not met, can result in significant fines of up to 20 million Euro or four percent of annual turnover. Maintaining compliance is required of...