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.

Company’s Keywords:

ethylene oxide & steam sterilization, health canada medical device establishment registration, natural health product licence & site licence applications for canada, adverse event reporting for various markets & coordinating product recall, product registration for the australian market & compliance with the tga requirements, strategizing regulatory pathway for various medical devices for global market access & registration, due diligence activities, clinical evaluation reports written in accordance to meddev 271 revision 4, tissues & cellular & tissuebased products, fda establishment registrations medical device listings us agent services for the us market, otc monograph drug products for the us market, 510premarket notification preparation, submission & fda communication, implementation of 21cfr part 1271 human cells, ce marking for the eu market technical filedesign dossier preparation for eu & other global markets, product label, canada & global compliance, implementation of the health canada good manufacturing practices guide for drug products, medical device regulatory consulting, sterilization expertise with radiation, assist with fda 483warning letter responses, medical device classification & licensing, implementation of the quality management system, insert & literature review for us, unique device identification