Delphi Consulting Group (DCG)

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Your Source for US FDA and Canadian Medical Device Release to Market

Home of the DCG iSubmission and iDocuments

Houston, Texas USA Based, Worldwide Service

Established in the year 1988

Experience Matters.

Telephone + 832-675-9281  -6 GMT, info@delphiconsulting.com

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Regulatory Assistance with medical devices and the U.S. FDA and Health Canada.

 

 

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ASSOCIATE GROUPS

COOPER CONSULTING SERVICE (CCS)

Established in 1986.  Medical Device design, prototype and testing regulatory services.

Cooper Consulting Service (CCS) has a broad range of engineering capabilities.  We have designed numerous medical devices, ranging from teaching products to critical care systems.  Our services are tailored to client needs and can range from turn-key product design to supporting a specific aspect of design or test.  Working with CCS puts 100+ years of engineering experience on your team!

CCS is committed to our customerís success and has worked with companies large and small, from all over the world.  Our team wants to help you bring your product from concept to commercial success!

Contact:

www.cooperconsultingservice.com  or phone +281-482-9786

 

 

 

The DCG Newsstand

DCG offers the following documents that contain useful regulatory information and/or the regulations themselves.  All files are in PDF format that will open in any PDF reader.

[Under Construction] Check back often as this list of documents will be up-dated when new documents of interest become available.

Some document files have Bookmarks that will allow you to move around in the document with ease. 

To view or download click on the "Click Here" words.

United States FDA


1.  21 CFR Part 820 in 8 1/2 by 11 inch format.  Click Here

2.  DCG Consulting Terms and Fees. Click Here

3.  FDA 510(k) Guidance on submission format. Click Here

4. Software Guidance for medical devices. Click Here

5. Software Validation -  a major subject in new submissions.  Guidance Click Here PP File Click Here

6.  Deciding when to submit a 510(k) for a change to an existing wireless telemetry medical device. FDA Guidance. Click Here.

7.  Why 90% of medical devices fail product safety testing during the first test runs.  Click Here. We thank ETL SEMKO for this.

8.  FDA 510(k) Process. This is a DCG document.  Click Here.

9.  Pre-Submission Program for Medical Devices.  Click Here

10. eMDR Electronic Medical Device Reporting.  Click Here

11.  Applying Human Factors and Usability Engineering to Medical Devices.  Two documents, the basic Guidance and document with list of Highest priority Devices for this requirement in 510(k) submissions.  Basic Guidance Click Here, and List Click Here.

12.  Predicate device selection, a Client Alert from DuVal & Associates.  Click Here.

13.  The 510(k) submission file structure matrix.  Click Here.

 14. Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act.  Click Here.

 15.  FDA Guidance on 3D printing.  Click Here

16. Dissemination of Patient-Specific Information from Devices by Device Manufacturers. Click Here.

17 FDA issues final ruling allowing medical device manufacturers to use stand-alone symbols on labels.   Click Here

18. FDA finalizes Guidance on extrapolating data for pediatric medical devices.  Click Here

 19.  Deciding when to submit a new 510(k) for change to an existing device.  Click Here

 20.  Software when to submit a new 510(k) for a change.  Click Here

 21.  Exceptions to UDI Requirement.  Click Here

 22. Benefit risk determinations in premarket review.  Click Here

 23.  Third Party Review Program, update.  Click Here

 24.  CDRH Outlines Regulatory Priorities for Fiscal 2017.  Click Here

 25.  MDR Reporting for manufactures.  Click Here

 26.  Factors to consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions  Click Here

27. User  Fees for  513(g) Requests for Information,  2017 with faqs.  Click Here

28.  The DuVal 6th Client Alert on 510(k)s.  Click Here

29.   FDA issues guidance updating Unique Device Identification Compliance Policy Click Here.

30.  Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Click Here.

Health Canada

1.  Guidance document "How to Complete the Application for a New Medical Device Licence." Click Here

2.  Canadian User Fee update. Click Here

E.U.

Guidance document on how to prepare a E U Technical File from Emergo.  Click Here

iDocuments

Contact DCG (info@delphiconsulting.com), for a list of free published documents retrieved from the Internet covering current FDA regulatory issues.

 

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Last modified: 05/09/2019

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