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Delphi Consulting Group (DCGroup) WORLD WIDE
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, harvey.knauss@gmail.com
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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 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 customer’s 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
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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.
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. FDA User Fee schedule through 2015. Click Here 2. FDA 510(k) Guidance on submission format. Click Here 3. Software Guidance for medical devices. Click Here 4. Software Validation - a major subject in new submissions. Guidance Click Here PP File Click Here 5. Deciding when to submit a 510(k) for a change to an existing wireless telemetry medical device. FDA Guidance. Click Here. 6. Why 90% of medical devices fail product safety testing during the first test runs. Click Here. We thank ETL SEMKO for this. 7. FDA 510(k) Process, overview, of recent (December, 2013) updates. Click Here. 8. Pre-Submission Program for Medical Devices. Click Here 19. eMDR Electronic Medical Device Reporting. 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 Cost comparison between Microsoft Office and SoftMaker Office products. If you or your company desires to reduce the cost of Office Suite programs read this. Click Here DCG uses SoftMaker Office 12 for all work. Open Source Software Open source software is something DCG respects and believes should be much more common for personal and small business use. Click here to read a very good article on this subject.
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Send mail to
harvey.knauss@gmail.com for
questions or comments about this web site.
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Check back often as this list of
documents will be up-dated when new documents of interest become available. 