Welcome to Medical Device Advice, Inc. Medical Device Consulting
We are dedicated to providing you with fast, reliable and cost effective Medical Device Consulting Services.
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OUR COMPANY
Medical Device Advice, Inc., is a highly experienced Medical Device Consulting firm. We have over 25 years of expertise in offering affordable value-added services across the globe to the medical device and pharmaceutical companies to achieve compliance to the US, Canadian, European and International Regulations.
We specialize in CER, 510(k) premarket notification, Pre-Submissions (Pre-Subs), Submission Issue Requests (SIRs),
513(g) Requests, CE Technical File preparations, Sterilization guidance, Quality Management System Implementation, Assistance in responding to FDA 483, FDA warning letter, notified body non-conformities, Label Compliance and overall Regulatory strategy planning for Medical Devices, Natural Health Products and Over-The-Counter Drugs.
From product concept to distribution, our Medical Device Advice team can provide guidance, support and solutions that would contribute to your success.
Our relationships with our clients are based on trust, dedication, integrity, and customer-focus.
We are a highly qualified team of individuals, with extraordinary work ethics who are always striving to take that extra-mile to ensure your satisfaction in meeting all regulatory requirements and getting market access to your product at the fastest time.
We look forward to serving your needs.
WE SPECIALIZE IN THE FOLLOWING AREAS:
Clinical Evaluation Reports written in accordance to MEDDEV 2.7/1 Revision 4
510(k)-Premarket Notification preparation, submission and FDA communication
Sterilization expertise with Radiation, Ethylene Oxide and Steam sterilization
CE Marking for the EU market- Technical File/Design Dossier preparation for EU and other global markets
Implementation of the Quality Management System
Implementation of 21CFR part 1271 (Human Cells, Tissues and Cellular and Tissue-Based products)
Product label, insert and literature review for US, Canada and Global Compliance
Assist with FDA 483/Warning Letter Responses
FDA Establishment registrations/ Medical Device Listings /U.S Agent Services for the US market
Health Canada Medical Device Establishment registration, medical device classification and licensing
Implementation of the Health Canada Good Manufacturing Practices guide for drug products (GUI-0001)
Natural Health Product Licence and Site Licence Applications for Canada
Adverse Event Reporting for various markets and
co-ordinating product recall
Product registration for the Australian market and compliance with the TGA requirements
Unique Device Identification
Strategizing regulatory pathway for various medical devices for global market access and registration
Due Diligence activities
OTC Monograph Drug Products for the US market
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