Medilink WM and MasterControl invite you to attend a free workshop to learn more about the changing medical device regulatory environments, successfully navigating audits and the value of using digital solutions for managing quality and compliance.
You will learn:
- The latest quality management system requirements for medical device manufacturing.
- Technical and risk management documentation requirements.
- The status of the EU’s Medical Device Regulation (EU MDR), which is set to replace the current Medical Device Directive (MDD) in 2020.
- What to expect with the changing EU regulatory landscape.
Highly-knowledgeable life sciences industry experts will provide valuable insight on these topics and demonstrate how medical device and component manufacturers can position themselves for success.
In addition to the educational experience, this workshop will include opportunities to network and learn from your peers about their best practices and use of technology to navigate regulatory pathways and achieve compliance.
08:30 – Registration, arrival refreshment
09:00 – Welcome & Introductions
09:15 – Medical Device Audit Fundamentals, Medical Device Single Audit Program (MDSAP)—Including the Regulatory Impact on Audits
Global regulatory bodies are collectively emphasising quality, product performance and continuous improvement over simply satisfying compliance in medical device development. This transformation is driven by more quality-focused audits, regulatory harmonisation and programs such as MDSAP. During this session, the presenters will discuss the current regulatory audit landscape and compliance audit fundamentals from preparation through execution and follow-up.
10:15 – Assessing Your Company’s Current Readiness for Implementing a Digital Quality Platform
The rapid emergence of digital technology in the life sciences arena means medical device manufacturers should closely follow trends in automation in order to remain agile and competitive in the market. This session looks at how advanced technologies are helping medical device companies more easily comply with regulatory quality, documentation and risk management requirements.
11:00 – Refreshment break
11:20 – Post market surveillance of MDR
The EU’s Medical Device Regulation (EU MDR) is set to replace the current Medical Device Directive (MDD) for the regulation of devices in 2020.
12:20 – Brief overview of MTC facility, followed by lunch
14:00 – Event concludes
Delivered by MasterControl, Medilink WM and Regulatory Affairs experts.
A limited number of attendees will have the option to a one hour tour of the MTC facility and witness how it can support the medical devices sector, along with many other key markets. Please note the MTC follows a strict security assessment and certain criteria must be met to conduct the tour. Based on first come first serve basis.
Please note the MTC follows strict security measures to access the building. Please ensure you read the ‘Access to MTC’ information on the booking page.