Delphi Consulting Group (DCG)
Your Source for US FDA Medical Device Release to Market
Home of the DCG iSubmission and iDocuments
Houston, Texas USA Based, Worldwide Service
Established in the year 1988
Telephone + 832-675-9281 -6 GMT, or James.Knauss@delphiconsulting.com
Regulatory Assistance with medical devices and the U.S. FDA and Health Canada.
To be added to Oracle e-mail list send message to info@delphiconsulting. Group
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!
Check out this CCS document: click here
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.
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.
These documents are subject to frequent updates, always check to ensure an update is available.
To view or download click on the "Click Here" words.
United States FDA
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
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.
31. FDA "Nonbinding Feedback After Certain FDA Inspections of Device Establishments." Click Here
33. Modifications to the List of Recognized Standards, Recognition List Number: 055. Ths document has a list of all Standards that have been updated, and/or removed. Click Here.
34. FDA's Safety and Performance-based Pathway: An Alternative To Substantial Equivalence For 510(k) Submission. Click Here.
35. Unique Device Identification System . . . Guidance for Industry and FDA Stall, July 7, 2021. Click here.
36. Third Party Review Organization Performance Report 2021. Click Here.
37. Electronic Submission Template for Medical Device 510(k) Submission. Draft for Comment only. However, history has shown the final will not change very much. Click Here
38. eSTAR is an older Electronic Submission Template with good suggestions. It will only open in Adobe DC Pro. Click Here.
Guidance document on how to prepare a E U Technical File from Emergo. Click Here
The EU's Medical Device Regulation (EU) 2017/745 - MDT. Click Here. NEW
Contact DCG (firstname.lastname@example.org), for a list of free published documents retrieved from the Internet covering current FDA regulatory issues.
To report errors please call +832-675-9281 or e-mail to James@delphiconsulting.com.
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