As the European medical devices regulations (MDR) enters its third year of application, the industry is striving to comply with MDR compliance in a challenging economic and regulatory environment.
As first movers approach their recertification dates, other companies are achieving their initial product and quality system certifications, while some industry players are still in the application phase to meet the transitional requirements.
At the same time, the regulatory system is scrutinised to see how it delivers on its promises of better regulation, less burdensome requirements, and competitiveness and attractiveness in a global perspective.
This year’s MedDev Day will focus on the attractiveness of the European regulatory landscape for medical devices, improvements made and future developments.
Delegates will get practical insights on:
- how to meet MDR requirements and cost of compliance,
- the comparison of the European system to other regulatory regimes and global regulatory and clinical strategy
- how to streamline and cost effectively meet post market obligations
- how to achieve recertifications in a least burdensome approach
- how to minimize efforts for phasing out MDD/AIMDD and how to successfully shift to MDR as for transition delegates
- latest developments on the regulation, EUDAMED and clinical standards
The one-and-a-half-day program features Industry and competent authority talks followed by interactive workshops to allow elaborate solutions for post market programs and clinical strategy.
Bassil Akra, Chief Executive Officer at AKRA TEAM
Arkan Zwick, Corporate Regulatory Affairs Director at CROMA Pharmaceutical
Who should attend?
The conference is aimed at medical device professionals from Regulatory Affairs, Quality, Clinical Operations, Medical Affairs, Post Marketing Surveillance departments working in Pharmaceutical, Biotechnology and Medical Device companies, CROs, Universities/Hospitals, Academic Research, Patient Associations and Healthcare Organisations, Competent Authorities, EU Commission and Regulatory Authorities.
It will be one day and a half, starting on the 7th of October in the afternoon.
Programme work in progress
Quote di iscrizione
€ 670,00 Early Bird fee until 09 September 2024
€ 790,00 Ordinary fee
€ 430,00 Freelance, Individual, Academy, Public Administration
Fee includes: seat at the conference, pdf copy of presentations of Speakers who allow the distribution, networking lunch, coffee breaks, organisational office assistance, certificate of attendance.
The conference will take place at:
Hotel Scandic Copenhagen
Vester Søgade 6, Copenhagen – Denmark
Centrally located, 500 metres from Copenhagen Central Station, this contemporary hotel offers stunning views of the lakes and the Copenhagen skyline. From Copenhagen Airport: only 12 km by car. By public transport (via metro or bus), journey time around 25-minutes.