Medical Device Product Life Cycle – Make compliance your success factor
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Join our Medical Device Quality Assurance and Regulatory Affairs conference: An international conference on medical device pre- and post-market strategies to maintain safety and effectiveness throughout the medical device product life cycle.
We will outline strategies, evaluate and demonstrate device safety and effectiveness during the entire product life cycle, starting from user needs, through design, manufacturing, and a proactive post-market surveillance, in close collaboration with your key stakeholders.
Agenda-at-a-glance
Day 1 – Pre-market perspectives
- How the industry work to meet both user needs and expectations from the buyers.
- From user need to product specification – real world example.
- Usability – how to implement it from scratch! – Workshop with different tracks: ‘Software’, ‘IVD Devices and ‘other Medical Devices’.
- Roles and responsibilities of Legal Manufacturer, Distributors and other economic operators.
- Global trends within medical device regulations and standards.
- How to manage the integration of multiple regulations and standards, in your development process.
- How does the industry succeed in meeting user needs, in design, delivery and communication? A caregivers perspective.
Day 2 – Post-market perspectives
- Contract manufacturing – what is considered as sufficient control over outsourced processes? The view of a NB and a Contract Manufacturer.
- As the “Person Responsible for Regulatory Compliance”; which key quality indicators do I need to be in control of?
- UK and Switzerland – is the role of Authorised Rep, Importer and Distributor the same, as for EU?
- Efficient and sufficient PMCF/PMPF – Workshop with different tracks: ‘Software’, ‘IVD Devices and ‘other Medical Devices’.
- Distributors – how to address and clarify responsibilities in areas like liability, traceability, Customer education, Vigilance and Post-Market Surveillance.
- Medical Device Marketing & claims – how shall we understand, and fully implement, the requirements of MDR& IVDR?
- Panel discussion – how can the medical device stakeholders work together, to reduce risk and promote innovation?
Registration
Don’t delay! Make the decision to attend, mark your calendars, and take advantage of our early-bird pricing and register today.