Date: September 2024 - February 2025
Time: 14:00 – 17:00 CEST
Location: Various locations in the Netherlands
Duration: 9 live sessions
Language: English
Price: € 990,-
Introduction
Are you a medical device startup looking to navigate the complex regulatory landscape and bring your innovative (in vitro) medical device to market? Our comprehensive interactive training suite is designed specifically for you!
In our expert-led training sessions, you'll learn amongst others:
- Proper Classification: Understand how to accurately classify your medical device to meet regulatory standards.
- Correct Design Stages: Master the essential design stages required for regulatory compliance and decide when to freeze your design.
- Clinical Data Relevance: Discover the importance of clinical data and how it supports your device approval.
- Quality Management System (QMS): Learn why a robust QMS is crucial and how to implement one effectively.
- Submission File Compilation: Get step-by-step guidance on preparing a flawless submission file for regulatory .
Who can attend?
Are you a medical device or IVD startup still navigating the development phase? This Suite is your gateway to accelerated growth and innovation. Join a curated cohort of early-phase visionaries and dive deep into the essential strategies and insights needed to catapult your startup to success.
Purchase a ticket today to secure a spot for one representative from your startup in our training sessions. The delegate from your startup may differ from session to session.
Gain knowledge and share experiences
Each session in our Startup Suite is designed to provide a comprehensive and collaborative learning experience. Here’s how the sessions are structured:
- 2 Hours of In-Depth Content Sharing: Dive into the essential topics with expert-led discussions and presentations. Gain valuable insights and practical knowledge to elevate your startup journey.
- 1 Hour of Dynamic Programming: Engage in interactive activities that emphasize knowledge sharing and collaborative learning. Work together with peers to solve problems, brainstorm ideas, and enhance your understanding of the subject matter and learn from each other.
- Closing with Drinks: End the session on a high note by relaxing and networking with fellow participants over drinks. This is a great opportunity to build connections, share experiences, and enjoy a casual and friendly atmosphere.
Full Program
- Introduction and Strategy, 10 September 2024 in Arnhem
- Design and Development, 12 September 2024 in Arnhem
- Design Verification and DHF/DMR, 24 September 2024 in Arnhem
- Risk Management, 26 September 2024 in Arnhem
- Design Validation, 17 October 2024, at briskr in Nijmegen
- Subcontracting and Transfer, 14 November 2024, location will be announced soon
- QMS, 12 December 2024, at UtrechtInc in Utrecht
- AI/GDPR/Data protection/Software, 9 January 2025, location will be announced soon
- Technical File and PMS/PMCF/PMPF, 13 February 2025 in Arnhem.
To learn more about the full program, a specification on each session and to learn more about it's trainers, visit our webpage.
Certification
All participants who complete the training suite will receive a Certificate of Participation.
Don't wait to register – spaces are limited and filling up fast. Secure your place now and ensure your medical device meets all regulatory requirements for a successful market launch!
In addition to this training suite, Qserve offers various additional services for startups. Click here to discover more.
Act now, because when it's full, it's full!
Qserve Experts hosting the training Suite: