Delphi Consulting Group (DCGroup)

WORLD WIDE

   Release to Market

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

 

 

 

Delphi Consulting Group (DCG), provides comprehensive medical device U.S. FDA  and Health Canada regulatory services.

 The following is a brief overview of services:

Key Services:

bulletUS FDA Premarket Notifications - DCG provides research, writing, testing monitoring, follow-through and/or review of FDA 513g, 510(k)s, Pre-IDE,  IDE, De Novo, PMA and Health Canada Application  submission.  DCG produced submissions have often resulted in less than normal review time.  Submissions have been completed and released to market for device manufactures located worldwide.  Consulting Activities and Product Experience.   File are shared with client, can be edited on line and client may add new files to listing.   DCG utilizes and supports the following software; Microsoft Office 2010, Apache OpenOffice 4, WordPerfect X7, Visio, Skype, EverNote, and DropBox, 
 
bulletNRC License - DCG has produced licenses submissions for sealed sources and Brachytherapy devices, CFR 10 Section 30.32XX and CFR 10 Part 71, packaging and transportation  Radioactive materials.
 
bulletBiocompatibility and Sterilization Validations - Product biocompatibility and sterilization validations and re-sterilization validations.  Work with testing laboratories to write protocols, monitor testing and completion reports.
 
bulletEMI and Safety Standards Testing - Work with testing laboratories to write protocols, monitor testing and completion reports.  Act as Agent for UL Listing. Monitor testing laboratory activities and provide engineering feedback.
 
bulletReplies to US FDA Form 483, Warning Letters and Seizure Actions -- DCG has extensive experience with preparing strategy for reply and follow up actions.
 
bulletReuse of Single Use Devices - Premarket submissions for Hospitals and Third Party Re-Processors to ensure compliance with regulations and laws.
 
bulletU.S. Agent - DCG provides U.S. Agent Services for Foreign Establishments per 21 CFR 807.40.  DCG is listed with the FDA as a "United States Agent for Devices" as defined in Section 417 of the Modernization Act of 1997. Foreign companies holding U.S. FDA release to market for a medical device offered for sale in the U.S. must have a U.S. Agent.   Please note that we do NOT provide FDA Agent representation for FOOD companies.

Fee Schedules:

    Click Here for a very generalized budget review of consulting and FDA fees for common device submissions.  Most tasks are worked on a project bases, a.k.a. fixed price.

Capabilities

The following is abbreviated list of general capabilities and  device experience.  

Consulting Activities

bulletFDA "Release to Market" via 510(k), IDE and PMA pathways
bulletHealth Canada Applications
bulletCGMP Quality System Development
bulletCGLP Quality System Development
bulletDesign Review and Records Facilitation
bulletRegulatory Project Management
bulletInvestment regulatory and risk review and analysis
bulletUS and International Safety Standards review and listing, i.e., UL and IEC 60601
bulletAssistance with FDA & State FDA Inspection, replies to FDA Form 483 notices
bulletRegulatory Retainer for small to medium size companies for general FDA regulatory needs

Technology Experience [abbreviated list]

bulletEndotracheal and Tracheal tubes
bulletPerfusion devices and tubing sets
bulletHeart, By-Pass pumps and patient sets
bulletOrthopedic devices
bulletOncology devices
bulletCatheters; Angioplasty, Vascular, Embolectomy and Monitoring
bulletLasers; YAG, Argon and CO2
bulletStents
bulletSyringes: Standard and Pre-Filled
bulletInstrumentation; Monitors, Diagnostics, Life Support
bulletDefibrillator/Monitor
bulletRespiratory devices; Ventilators, O2 Concentrators, Anesthesia Equipment
bulletUltra Sound devices
bulletDoppler Devices with Probes
bulletNuclear Devices
bulletHigh/Low Dose Rate Brachytherapy
bulletVascular Products; Angioplasty, Surgery Kits
bulletElectrodes
bulletCancer Detection Instrumentation
bulletMonitoring Equipment; EEG, EKG, Anesthesia, Blood Gas, and ICU Systems
bulletInfant Incubators, Warmers and Phototherapy Lights
bullet

Gynecological Devices and Instruments

bulletPowered and non-powered surgical instruments
bulletX-Ray, MRI, CT and PET scanners and cameras
bulletOsteosynthesis Systems

 

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Copyright © 2019 Delphi Consulting Group
Last modified: 08/14/2019

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