Premarket Notifications - DCG provides research, writing, testing monitoring, follow-through and/or review of FDA 513g, 510(k)s, Pre-IDE,  IDE, De Novo and PMA 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.
	NRC License - DCG has produced licenses submissions for sealed sources and Brachytheray devices, CFR 10 Section 30.32XX and CFR 10 Part 71, packaging and transportation  Radioactive materials.
	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.
	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.
	Replies to FDA Form 483, Warning Letters and Seizure Actions -- DCG has extensive experience with preparing strategy for reply and follow up actions.
	Reuse of Single Use Devices - Premarket submissions for Hospitals and Third Party Re-Processors to ensure compliance with regulations and laws.
	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.

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

Consulting Activities

	FDA "Release to Market" via 510(k), IDE and PMA pathways
	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

	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
	Gynecological Devices and Instruments
	Powered and non-powered surgical instruments
	X-Ray, MRI, CT and PET scanners and cameras
	Osteosynthesis Systems