Testimonials

"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"
"Spectre Solutions absolutely proved themselves to be fast, efficient, courteous, very conscientious and highly dependable."
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Spectre Solutions is a consulting firm located in Ohio that specializes in medical device regulatory compliance, and quality system development. We assist manufacturers, exporters, importers and distributors of medical devices in understanding the regulations, and implementing processes, procedures and policies to comply with them.

Our areas of expertise include FDA & ISO regulatory issues, 510(k) submissions, CE Marking requirements and quality system development. We also perform audits, provide training and assist in working with FDA on compliance issues such as 483's and FDA Warning Letters. The services we offer include:

    QSR/ISO Audits and Gap Analysis
    QSR/ISO Training
    Internal Auditor Training
    Design Control Implementation, Audits & Assessments
    Risk Assessment & Hazard Analysis Consulting
    510(k), IDE, PMA Submissions
    Device Import/Export Consulting
    Medical Device Directives (CE Marking) Consulting

If you have a question or would like to discuss your needs, please contact us at (440) 546-9810, or by email at info@spectresolutions.com . If you would like us to quote a specific project, just complete the "Request Quote" form and submit it to us. We will respond to your request within 3 working days.