Medical Devices & Biosciences International...

Company Description

Medical Devices & Biosciences International is a regulatory affairs agency with an office in North America. We focus on assisting companies to develop their product within quality systems and regulations to formulate market entry and business development programs.The hands on experience gained from the Global Harmonization Task Force (GHTF), dealings with the various government regulatory agencies, quality systems registrars, manufacturing, operations, national and provincial associations, export and imports, international standards and various technologies provides us with an understanding of the customers needs.Products and ServicesWe will provide consultants for medical devices and biosciences technologies services and ensure that the products comply with the Medical Devices Regulations and the Food and Drug Act/Administration. We provide direction to get the product to the market in a timely manner.We are a global business firm, and represents businesses in Asia, North America and around the world. Our expertise, have taken us beyond the borders of Canada.Our services consist:- Act as your company Agent- Verification- Regulatory- Technical Files- Establishment Licensing/Private Labeling- Pre-market Approvals- ISO/GMP/Training- Market access strategies- National Language Issues- Investigational Testing Authorization- Sterilization /Single use/ Re-useable- Partnerships/Set up distributors