Testimonials

"I tried working with two other regulatory companies before working with Spectre Solutions. Ed Kroll was the first person to really explain and setup a quality managements system (QMS) that perfectly fits our company's business. MIMvista QMS is proof that spending the time and the money implementing it right the first time will save your company ten fold in the future. Ed Kroll's experience and passion gives him the ability to create clear and concise documentation for his clients, and that is what it is all about."

Pete Simmelink
COO
MIMvista Corp
Cleveland, OH 44122

As a small medical instrument manufacturer, ScottCare Corp has relied on Spectre Solutions primarily for our internal audits. Spectre Solutions helped us customize the scope or focus of these audits to be specific to the standards of interest (US, Canada or Europe). In addition, they offered us solutions to ensure our Quality Management System was ready for the ISO auditors. "We obtained our ISO 13485:2003 certificate expeditiously, and could not have done so without Spectre Solutions assistance. After all, time is money. Getting quality products to market sooner helps our bottom line".

David Blattenberger,
Manager of Quality Assurance and Regulatory Affairs,
ScottCare Corporation,
Cleveland, OH

"Over the past several years, I have tried using the services of various quality system consultants with less than acceptable results. It was not until employing Ed Kroll from Spectre Solutions, that requirements of the regulations started making sense. His background and experience in the medical device manufacturing environment allow him to offer practical and effective solutions to sometimes confusing quality system and regulatory requirements. I have used Ed Kroll to conduct QMS training, provide independent assessments of our quality system, and as an information resource. I would highly recommend him in this regard."

David C. Simo
Director of Quality and Regulatory
Western/Scott Fetzer Company

"When our company needed assistance in constructing our Quality System Procedures, Work Instructions and Quality Policy Manual, Spectre Solutions was right there for us. They thoroughly understood our requirements and then provided documentation that was concise, well-written and useful. Without question, Spectre Solutions absolutely proved themselves to be fast, efficient, courteous, very conscientious and highly dependable. From the very first day, they treated our business as if it were their own business, which is an exceptionally rare commodity. Their knowledge, expertise, kindness and patience were all invaluable. We would not hesitate to hire them again."

Mark E. Tulin
President
Perma-Type Rubber

"We have found Ed Kroll to be very effective in building simplicity and practicality into our quality system. He understood the constraints of a company our size and revised our quality system to make it responsive to our specific needs. His hands-on work and leadership resulted in a "pass" for our FDA Inspection and BSI ISO 13485:2003 Assessment.

Paul G. Amazeen, Ph.D.,
Executive VP & CTO
Imalux Corporation

"In the past few years, we have used Spectre Solutions for internal audits, 510(k)'s and quality system procedure development. What separates Ed Kroll from other consultants we've used is his practical approach to regulatory compliance and quality systems, along with his willingness to become a part of the company he is working with. He has helped us develop simple, yet effective programs, which are not cumbersome and are designed specifically for what it is we do."

Frank Valentino
Senior Director PET/CT Engineering
Philips Medical
Highland Heights, Ohio