Bringing a medical device to market requires successfully navigating a complex regulatory landscape. It is crucial that manufacturers and supply-chain stakeholders are aware of, understand, and effectively implement these requirements to achieve market entry.
Overview
This course focuses on the requirements applicable to medical devices when bringing them to market. It covers the following topics and supports you in answering these key questions.
Key Topics
- Scope of medical devices: Is your product a medical device and how can you judge?
- Device classification: What is the devices’ classification and how can you determine it?
- Market entry pathway: Which route to market applies to your product and what does it require?
- Applicable regulatory requirements: What are the key standards? What do they look like and how can you fulfil their requirements?
- Basic safety & essential performance (IEC 60601 series), quality management systems (ISO 13485), risk management (ISO 14971), usability engineering (IEC 62366-1), software lifecycle processes (IEC 62304), and cybersecurity (IEC 81001-5-1)
Duration
3 hours
Who Should Attend?
This course is aimed at organizations that are developing medical devices and want to understand the different types of regulatory requirements that are applicable to their products. However, all medical device supply-chain stakeholders can benefit from participating in this course.
Language
English
Venue
2/F Garment Centre, 576 Castle Peak Road, Kowloon, Hong Kong
If you are interested in the above courses, please register using the request button below with the corresponding course topic/code and preferred schedule.
Training
Equip your team with essential information via Intertek training opportunities.
