MEDICAL DEVICE CONSULTANT
REGULATORY CONSULTING SERVICE
OUR HANDS ON APPROACH PROVIDES AN INTERDISCIPLINARY EXPERIENCE IN ASSISTING INDUSTRIES REGULATED BY FDA AND INTERNATIONAL HEALTH AGENCIES.
Seeking FDA Emergency Use Authorization for a COVID-19 medical device?
Med-Device Consulting, Inc. provides a wide range of personalized regulatory and quality assurance consulting services that meet your company’s needs and help manufacturers in their regulatory affairs for marketing and distributing their products in the United States and Europe. We support your company’s needs for the FDA Quality Assurance and Regulatory systems, MDSAP Audit program, EU market, CE mark preparation, 510(k) submissions, and ISO Quality system preparation for certification.
We can guide our clients to determine whether your device is eligible for an Emergency Use Authorization (EUA), or how to seek an EUA, regulatory hurdles, we can help the makers of devices that are not EUA-eligible.
A highly-experienced, focused, and flexible consultant of experts who will help see your project through to completion the right way.
- Complete Quality System development FDA and ISO 13485:2016 consulting and gap analysis
- Risk assessment & hazard analysis consulting
- Part 11, 210, 211 and 820 Compliance review
- Quality system review, then develop and implement a remediation plan, if applicable
- FDA, ISO 13485:2016, MDSAP, and CE medical device safety consulting
- Device Class and Regulatory Controls:
- Class I General Controls
- Class II General Controls and Special Controls
- Class III General Controls and Premarket Approval
and much more...
- Biocompatibility tests required for examination and surgical gloves
- FDA Registration - Latex and Nitrile gloves
- Tests required for latex and nitrile gloves
- Premarket Notification (510k)
- Establishment Registration
- Medical Device Labeling
- ISO 13485 certification
- UDI submission
- CE Marking
- 21 CFR 820
- FDA Registration Certificate
- FDA Registration Renewal
- U.S. FDA Agent Requirements
- FDA Agent Services
- Food Registration
- Export Certificates
- FDA Registration & US Agent
ARE WE UNDERSTANDABLE?
Our Mission is to provide an accurate and truthful explanation of the regulations in the most cost-effective way; preparing and reviewing quality regulatory submissions and delivering customized training seminars to our clients.