Medical Device Advice, Inc.

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 ethic, who always strive to go the extra-mile to ensure your satisfaction in meeting all regulatory requirements and gaining market access to your products at the fastest possible time. We look forward to serving your needs.

• Employees 1
• Founded 2018