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 Details
- Founded
- -
- Address
- Caledon, Ontario L7e 4c9, Ca
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Keywords
- Medical Device Regulatory Consulting, 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.
- HQ
- Caledon, Ontario
- Competitors
- Medical Device Manufacturing, Medical Device Reprocessing Consulting Services, Canadian Association of Medical Device Reprocessing, Canada's Medical Device Technology Companies, Medical Device Development Centre (MDDC), Medical Device Repair, medical device, Medical Device Product Development, StarFish Medical, Baylis Medical.
Medical Device Advice, Inc. Questions
Medical Device Advice, Inc.'s website is https://medicaldevice-advice.com/
Medical Device Advice, Inc.'s LinkedIn profile is https://ca.linkedin.com/company/medical-device-advice-inc
Medical Device Advice, Inc.'s industry is
Medical Equipment Manufacturing
Medical Device Advice, Inc.'s top competitors are
Medical Device Manufacturing,
Medical Device Reprocessing Consulting Services,
Canadian Association Of Medical Device Reprocessing,
Canada's Medical Device Technology Companies,
Medical Device Development Centre (Mddc),
Medical Device Repair,
Medical Device,
Medical Device Product Development,
Starfish Medical,
Baylis Medical.
Medical Device Advice, Inc.'s categories are Medical Equipment Manufacturing
Medical Device Advice, Inc.'s founding year is 2018
