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Information Resource Center

Here you'll find information and resources to help you focus your efforts as you go through the medical device regulatory compliance process.

Browse the links on the left for a listing of articles and papers published by our staff, details on upcoming seminars, events and trade shows, and links to industry resources, organizations and government sites that we've found to be useful.

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Free Documents

Preparing a Successful 510(k) Submission (pdf)

This easy-to-use primer on submitting your product for FDA clearance, is the first of a two part series. Part one covers FDA medical device classification, the contents of a 510(k) premarket notification, and FDA's criteria for determining substantial equivalence. Originally published in Medical Product Outsourcing, April 2004.

Abbreviated and Special 510(k)s (pdf)

Part two of the series of articles published in Medical Product Outsourcing. This article describes how the use of Abbreviated and Special 510(k)s and third-party reviews can speed the FDA clearance process for medical device manufacturers. Originally published in Medical Product Outsourcing, June 2004.

Ten Mistakes to Avoid When Bringing Your Medical Product to Market (pdf)

This guide points out some critical issues to consider as you prepare to bring your medical device to market.

Understanding the Role of European Regulatory Bodies & Checklist for Selecting A Notified Body (pdf)

To comply with the European Medical Device and IVD Directives, manufacturers need to select a notified body. This document discusses the roles of European regulatory bodies and includes a helpful checklist of items to consider when selecting your notified body.

Points to Consider When Selecting a European Authorized Representative (pdf)

Medical device manufacturers located outside the European Union wishing to market a product in Europe must designate a European Authorized Representative (AR), who will act their behalf, and whom authorities may contact in their place. This article provides important items to consider when choosing your representative.

The 10 Common IVDD Compliance Pitfalls

Careful planning can significantly reduce the cost and time necessary to attain the CE Mark for your IVD products. Don't fall victim to these ten common pitfalls.

Clinical Study Specifications Questionnaire (pdf)

Are you developing a medical device or diagnostic clinical study, but unsure of the potential costs involved? This confidential questionnaire covers important cost elements, including a breakdown of regulatory, clinical and QA tasks and responsibilities. We will review your answers and help you to develop a plan to successfully implement your clinical study.

Essential Requirements Checklists

These easy-to-use checklists list the General Requirements for the European Medical Device and IVD Directives. Each includes columns for your additional information.

IVDD Essential Requirements Checklist (DOC, 177KB)
MDD Essential Requirements Checklist (DOC, 315KB)

Free Document from FOI Services

Each week you can download a complimentary document of interest to the FDA-regulated community. Download this week's free document courtesy of FOI Services.

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