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
Delphi Consulting Group (DCG) is a consulting company specializing in medical device US Food & Drug Administration and Health Canada release to market. Use of Internet and video conference reduces need for travel to zero, thus, reducing project costs.
Why Choose Delphi Consulting Group?
Delphi Consulting Group (DCG), provides comprehensive medical device release to market. DCG provides full turnkey submissions working as a facilitator. Download FDA 510(k) requirements document as prepared by DCG - Click Here.
DCG will monitor testing laboratories and their reports for suitability to requirements. Prepare submissions, monitor FDA review and provide counsel on any FDA request for additional information (AIs) or Refuse to Accept replies.
DCG provides comprehensive new device review and risks analysis to investment groups.
DCG can, based on degree of known data, provide a not to exceed (NtE), cost budget for 510(k) submissions.
DCG will help you during the US 510(k), 513g, IDE, PerSub or PMA and/or Health Canada submission process by:
NRC listing and license for Medical Sealed Sources with Federal
and Agreement States regulatory agencies
Prepare customized Quality System Regulatory SOPs for US FDA GMP (CFR 21 - Part 820), compliance.
Regulatory control software from Grand Avenue Software Company. DCG recommended.
DCG provides FDA required US Agent Services for companies outside of the U.S.
MDSAP Audit Plan
DCG can provide assistance with setting up and conducing MDSAP (Medical Device Single Audit Plan). It looks like this will be a requirement in Canada, Japan, Australia, and USA soon. Contact DCG for details on this new audit plan and how it will effect your company.
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