Meet the Experts Spain: The Journey to Market Readiness
What is the event about?
Navigating CE marking, UKCA marking, ISO 13485, and MDSAP certification can be complex: from initial application and conformity assessment through to post-market surveillance.
This event brings you face to face with BSI's regulatory experts and technical specialists, sharing their knowledge of what good submissions look like, how to avoid common pitfalls, and how to stay ahead of evolving requirements. You'll also hear the latest updates on MDR, IVDR, and other topics shaping the industry.
Beyond the programme, you'll have the opportunity to connect with your peers across the MedTech community, asking questions, exchanging experiences, and building valuable networks.
Whether you're bringing your first device to market or managing an expanding portfolio, this event gives you the knowledge and connections to move forward with confidence.
Registrations are open until 7 September.
Why Attend?
- The latest MDR and IVDR updates, including current timelines and regulatory requirements;
- Insight into what makes a strong submission, and how to avoid common pitfalls;
- Clarity on the conformity assessment process, from application through to post-certification;
- Best practice guidelines on planning timelines and preparing documentation;
- FAQs sessions with BSI regulatory experts; and
- Networking with BSI assessors, technical specialists, and MedTech peers.
Who Should Attend?
Regulatory Affairs (RA) and Quality Assurance (QA) professionals involved in submissions and compliance;
R&D teams designing products with regulatory requirements in mind;
Startups navigating MedTech certification for the first time;
SMEs strengthening their regulatory readiness; and.
Established manufacturers seeking clarity on evolving requirements.
You can book a 1-to-1 meeting with a representative of our team.
Up to 2 participants per company will be admitted to the event to allow diversified companies to participate and engage.
What to expect?
- Insightful presentations– BSI's regulatory experts share knowledge on navigating MedTech compliance.
- Interactive Sessions – Direct engagement with regulators to clarify expectations and address compliance concerns.
- Network with Industry Peers – Connect with like-minded startups and key stakeholders in the HealthTech ecosystem.
Event Details
WHEN
WHERE
Barcelona Health Hub
Access to the venue is through the Main Entrance Vestibule
