We specialize in the following areas: medical devices, cosmetic products, personal lubricants, and nutraceuticals.
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About MED-DEVICE CONSULTING
Our Mission
At MED-DEVICE CONSULTING, our mission is to provide exceptional consulting services that empower our clients to achieve their business goals. We strive to deliver customized solutions that meet the unique needs of each client.
THE MISSION OF MED-DEVICE CONSULTING, INC. IS TO ASSIST COMPANIES IN MEETING THEIR STRATEGIC OBJECTIVES BY PROVIDING HIGHLY SPECIALIZED EXPERTISE AND ASSISTANCE ON A PROJECT, TEMPORARY OR ON-GOING BASIS.
US FDA 510(k) Submissions - 510(k) submissions for Personal Lubricants, FDA submissions done faster, done smarter.
MDSAP Audit Preparation, new European Medical Device Regulation (MDR)
management consulting - Full-service regulatory consultancy.
Our experienced regulatory consulting and compliance team commands an unparalleled breadth and depth of knowledge pertaining to the US and European regulatory frameworks and can work with you to accomplish your business objectives. Using our deep science knowledge, our regulatory team develops and executes detailed strategies for your product, providing a clear path forward through all the critical milestones to achieve a successful outcome, whether a submission or a meeting. We also support post-authorization regulatory operations, including product launch and publications review. We maintain your product's regulatory status throughout its lifecycle. Our track record of success in both the US and Europe is unmatched. As the only genuine global consultancy, our chemists and regulators have helped hundreds of small and large firms move their products from one regulatory hurdle to the next. We work collaboratively with your team from the initial analysis to the final submission of 510(k) when necessary, with positive results.
Our Team
Our team is made up of highly skilled consultants with a wealth of experience across various industries. We bring together our diverse expertise to provide cutting-edge solutions that drive success for our clients.
M-DCI stands out as a premier regulatory consultancy organization and a trusted leader in U.S. FDA and international quality and regulatory affairs compliance programs. We pride ourselves on delivering exceptional service in the medical device, cosmetic, personal lubricant, and nutraceutical/dietary supplement sectors.
With over 30 years of proven experience, we are your dedicated partner in achieving compliance and excellence.
- 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 FDA and ISO 13485:2016 consulting, 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.
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!
- FDA Registration & US Agent
SERVICE
What M-DCI Can Offer
Leveraging Med-Device Consulting, Inc.'s successful business strategy, our highly experienced team specializes in U.S. and EU compliance. With extensive knowledge in technology startup ventures, operations, manufacturing, regulatory affairs, and quality assurance, we offer companies an effective and cost-efficient solution to safeguard their products and ensure uninterrupted shipments.
- GMP (Good Manufacturing Practices) Certification preparation, US FDA QSR (cGMP), US FDA 21 CFR 820, 210 and 211, US FDA Quality Systems Inspection Technique (QSIT)
- Training: GMP, Quality System Regulation, Design Control, Process Validation, Compliance programs, MDSAP, MDD, IVDR, ISO 13485, ISO 9001 and ISO 14971
- Audit results evaluations, interpretations, and corrective action plan
- Medical Devices Product (CE mark) Technical Files Compilation, submission/registration
- Achieve regulatory compliance through implementation and certification processes that ensure your organization meets industry standards.
- Conduct thorough internal and supplier audits and assessments to identify and mitigate risks.
- Drive success by effectively executing corporate strategies tailored to your organization’s goals.
- Enhance your team’s expertise with comprehensive training in Good Manufacturing Practices (GMP), Quality System Regulation (QSR), Design Control, and Process.
- Build strong, reliable supplier and vendor relationships that contribute to sustainable growth.
- Respond quickly and effectively to FDA Inspection Form 483 and Warning Letters with robust corrective action plans to safeguard your business.
- Navigate consent decrees and "483" remediation processes to maintain your company's reputation and operational integrity.
- Ensure effective product recall management with our expert assistance to minimize impact and protect your brand.