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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 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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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:
 | US 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,
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| NRC 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.
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| Biocompatibility and Sterilization Validations - Product
biocompatibility and sterilization validations and re-sterilization
validations. Work with testing laboratories to write protocols, monitor
testing and completion reports.
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| EMI 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.
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| Replies to US FDA Form 483, Warning Letters and Seizure Actions
-- DCG has extensive experience with preparing strategy for reply and
follow up actions.
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| Reuse of Single Use Devices - Premarket submissions for
Hospitals and Third Party Re-Processors to ensure compliance with regulations
and laws.
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| U.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
| FDA "Release to Market" via 510(k), IDE and PMA pathways |
| Health Canada Applications |
| CGMP Quality System Development |
| CGLP Quality System Development |
| Design Review and Records Facilitation |
| Regulatory Project Management |
| Investment regulatory and risk review and analysis |
| US and International Safety Standards review and listing, i.e., UL and
IEC 60601 |
| Assistance with FDA & State FDA Inspection, replies to FDA Form 483
notices |
| Regulatory Retainer for small to medium size companies for general FDA
regulatory needs |
Technology Experience [abbreviated list]
| Endotracheal and Tracheal tubes |
| Perfusion devices and tubing sets |
| Heart, By-Pass pumps and patient sets |
| Orthopedic devices |
| Oncology devices |
| Catheters; Angioplasty, Vascular, Embolectomy and Monitoring |
| Lasers; YAG, Argon and CO2 |
| Stents |
| Syringes: Standard and Pre-Filled |
| Instrumentation; Monitors, Diagnostics, Life Support |
| Defibrillator/Monitor |
| Respiratory devices; Ventilators, O2 Concentrators, Anesthesia Equipment |
| Ultra Sound devices |
| Doppler Devices with Probes |
| Nuclear Devices |
| High/Low Dose Rate Brachytherapy |
| Vascular Products; Angioplasty, Surgery Kits |
| Electrodes |
| Cancer Detection Instrumentation |
| Monitoring Equipment; EEG, EKG, Anesthesia, Blood Gas, and ICU Systems |
| Infant Incubators, Warmers and Phototherapy Lights |
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Gynecological Devices and Instruments |
| Powered and non-powered surgical instruments |
| X-Ray, MRI, CT and PET scanners and cameras |
| Osteosynthesis Systems |
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