A challenge common to all medical device manufacturers is conducting a regulatory submission which is both effective and efficient. Successful submissions with devices that utilize colorants are less likely to go off without a hitch. What exactly is the perspective of the FDA with regard to Colorants in Medical Devices? What testing is a Medical Device Manufacturer expected to conduct to support the use of a colorant in a medical device? What about the Colorant Manufacture’s Master File with the FDA… will that address testing requirements?
This presentation will provide answers to many of these inquiries and more. John Iannone from Toxikon Corporation will discuss the regulation of colorants in medical devices and present solutions to many of these challenges, therefore preparing you for the attainment of a successful regulatory submission. Discussion topics will include:
- What you need to know about USP Class VI(6) vs. ISO 10993
- Biocompatibility Testing considerations of colorized devices
- What information a Device Manufacture can obtain from the colorant manufacturer?
- Chemical Characterization of Materials as it applies to proprietary colorants
- Toxicology Risk Assessments of Colorized Devices
- FDA approved color additives for Medical Devices
Mark Thomson, MBA, NA Sales & Marketing Manager, Arazy Group Consultants Inc.
Mark is a business consultant and sales & marketing expert with an extensive record of achievement within the global medical technology and healthcare services industry. Since 2013, Mark has been acting as North American Sales & Marketing Manager for Arazy Group Consultants Inc., helping medical and IVD device manufacturers around the world to successfully launch their products in multiple markets through Arazy Group’s flagship service LICENSALE.COM™.
John Iannone, Program Manager – Extractables/Leachables & Special Studies, Toxikon
Since joining Toxikon in 2004, John has assisted several drug and medical device developers with the development of product safety testing strategies. His areas of expertise include biocompatibility testing of combination devices, material characterization, and study design for custom microbiological and extractable/leachable studies. His responsibilities focus on providing technical support in client interface regarding unique testing requirements and facilitating the attainment of sound technical risk assessments of medical devices.
Who Should Attend?
Senior level executives involved in regulatory affairs for medical device companies, including those from manufacturing services providers, consulting companies, financial/investment companies and government.
Relevant job functions include:
- Engineering (Biomedical, Design, Manufacturing/Production, Packaging, Process, Project, Quality, R&D)
- Manufacturing (Packaging, Process)
- Project Management
- Research & Development
- Regulatory / Compliance / Quality Assurance
- Sales / Business Development / Marketing
The session will also benefit pharmaceutical, biotechnology and dental product manufacturers.
Toxikon Corporation is a preclinical contract research organization. We contract and partner with biotech, Pharmaceutical and medical device industries to deliver exceptional product development services from concept to final product.
Arazy Group Consultants Inc. is a global, multifaceted regulatory affairs firm that provides all types of medical device manufacturers with client-specific solutions throughout the product life cycle – from early development to post-market activities. With over 19 years of expertise, our experienced consultants are responsible for the successful registration of thousands of medical devices in 100 countries worldwide. Arazy Group is based in Vancouver, British Columbia, Canada. Our flagship product, LICENSALE.COM™, is our new, simple solution for registering medical devices globally.