About Medical Device Consulting
Regulatory Compliance Expertise
At MED-DEVICE CONSULTING, we’re on a mission to elevate your medical device journey! Our expert guidance on FDA submissions, ISO standards, and European regulations empowers your products to navigate compliance with ease and precision. We specialize in areas including medical devices, cosmetic products, personal lubricants, and nutraceuticals. Join us in transforming challenges into opportunities! Our passionate team is dedicated to helping your business thrive, ensuring you confidently navigate the landscape of medical device consulting while embracing excitement. Let’s achieve greatness together!
Our Team
With over 30 years of proven experience, we are your dedicated partner in achieving compliance and excellence while navigating both FDA submissions and European regulations.
- Our team of experts is committed to guiding your projects to successful completion, ensuring the right outcomes every step of the way.
- We specialize in complete quality system development, providing comprehensive consulting for FDA submissions and ISO standards, including ISO 13485:2016, along with targeted gap analysis.
- Our risk assessment and hazard analysis consulting services identify potential issues before they arise, safeguarding your operations.
- Enjoy peace of mind with our thorough compliance review for Part 11, 210, 211, and 820 regulations.
- We conduct meticulous quality system reviews and will create and execute effective remediation plans as needed.
- Our extensive safety consulting covers FDA, ISO 13485:2016, MDSAP, and CE medical devices, positioning you for success in both domestic and international markets.
We expertly navigate a variety of regulatory controls, including:
- Class I General Controls
- Class II General Controls and Special Controls
- Class III General Controls and Premarket Approval
In addition, we support your needs with:
- Biocompatibility tests for surgical gloves
- FDA registration for both latex and nitrile gloves
- Adhering to testing requirements for gloves
- Premarket Notification (510(k))
- Establishment registration and medical device labeling
- ISO 13485 certification and UDI submission
- CE marking and compliance with 21 CFR 820
- Assistance with FDA registration certificates and renewals
- Navigating U.S. FDA agent requirements and services
- Food registration and export certificates
Partner with us for your regulatory needs, and let’s ensure your success together in meeting both FDA and European regulations!