Online Training
UKCA - An Introduction
Understanding the UK Regulatory Landscape and Preparing for Future Regulations
Available Dates & Times
● new dates coming soon
Description
This course is designed to provide a detailed understanding of the UK regulatory landscape for medical devices or in vitro diagnostic devices, focusing on how to navigate current regulations, prepare for future changes, and develop an effective transition strategy.
The training will also cover essential post-market surveillance requirements to ensure ongoing compliance.
This course will help training participants gain in-depth knowledge about the UK’s evolving regulatory environment and learn how to prepare for upcoming changes, including post-market surveillance requirements and developing a robust transition strategy.
Net price
€ 499
- Access to online training
- Presentation slides as handout
- Participation certificates
Overview of covered topics
- Detailed structure of the UK Medical Device Regulations
- Understanding the transitional periods for new regulations
- Developing and implementing a transition strategy
- Roles and responsibilities of key stakeholders
- Implementing post-market surveillance activities
- Quality Management Systems and marking requirements
- Registration requirements
- Northern Ireland-related regulatory topics
Purpose of the training
The following targets are aimed at:
- Understand the current and upcoming UK regulatory requirements
- Learn how to prepare for future regulatory changes
- Develop a transition strategy for compliance
- Learn about upcoming post-market surveillance practices
- Understand specific regulatory considerations related to Northern Ireland
Who should attend
- Manufacturers and other economic operators
- Regulatory specialists
Basic knowledge required
- No prior knowledge required
- This course is suitable for anyone looking to gain a comprehensive understanding of UK medical device regulations, regardless of prior knowledge or experience.
Presenting expert
Hilola Hakimova, MSc
Clinical Consultant
AKRA TEAM GmbH
Dr. Anna Spehl
Senior Consultant
AKRA TEAM GmbH
Norchéne BenMadhi
Consultant
AKRA TEAM GmbH
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Support & Training
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