July 2018 News

Medical Product Compliance Webinar Series

In this webinar series, you’ll gain insights into technical requirements, the standardization process, developments of IEC 60601-1- family, steps the manufacturer must perform fulfill risk management requirements, new methods of risk analysis, navigating the FDA’s device approval process, new immunity requirements to mitigate electromagnetic interference and best practices in determining & mitigating potential adverse events... Read More

Active Medical Device Compliance Seminar

This seminar will help you at every point of the product lifecycle from development to market entry including: Understanding Global ME regulations and market access requirements (US NRTL/FDA, EU MDD, IEC CB Scheme); Compliance testing; Implementing good risk management and performing post-market surveillance; Handling data and documents for regulatory submission. You will learn critical knowledge... Read More