Are you an R2B team, startup, or individual working in health tech innovations? Navigating the complexities of health technology commercialization can be challenging, especially with stringent regulatory requirements. Labquality is here to help you overcome these challenges with our exclusive training session: Health Tech Regulations, Quality Management, and Commercialization.
Why You Should Attend
Commercializing health tech innovations is not just about having a great product; it's about ensuring that your product meets the regulatory standards and is ready for market entry. Our training session will give you essential knowledge and practical skills to excel in this competitive field.
Training Details
- Date: October 8, 2024
- Time: 9:00 AM - 4:00 PM
- Format: Online
- Price: €750 + VAT 24% (Group discounts available!)
What You Will Learn
Our training session covers critical aspects of health tech commercialization:
- Innovating in a Regulatory Industry: Understand health tech innovation's unique challenges and opportunities.
- Commercialization of Medical Devices: Learn strategies for successfully bringing your medical device to market.
- Quality Management According to ISO 13485: Gain insights into the quality management systems essential for compliance.
- Medical Device Development Standards: Get acquainted with key standards such as IEC 62304, ISO 14971, and more.
- 1-to-1 Sparring Sessions: Benefit from personalized guidance on your challenges and questions.
Meet Our Expert Trainers
Mikko Juuti
Key Account Manager
Mikko Juuti is a seasoned expert with over 20 years of experience in medical device commercialization. His extensive background includes roles at Labquality, Kasve, VTT, and the University of Eastern Finland. As an investor in deep tech and a key figure in several technology startups, Mikko brings knowledge and practical insights to the training.
Terhi Heikkinen
Quality & Regulatory Affairs Manager
With over two decades of experience, Terhi Heikkinen specialises in product development, quality, and regulatory affairs. She has successfully managed quality management systems and technical documentation to achieve QMS certification and product registration. Her expertise spans project design control, risk management, verification and validation activities, CE and 510(k) submissions, and compliance with various international standards.
Who Should Attend?
This training is perfect for R2B teams, startups, accelerators, and individuals involved in health tech innovations. Whether just starting the commercialization process or preparing a medical device for market entry, this session will provide the tools and knowledge you need to succeed.
Key Benefits
By attending this training, you will:
- Apply Key Standards: Learn to implement the most common health tech standards in your projects.
- Avoid Pitfalls: Identify and navigate common pitfalls in medical device commercialization.
- Enhance Skills: Improve your competencies in quality assurance and regulatory affairs.
- Innovate and Collaborate: Strengthen your ability to innovate, collaborate, and continuously develop your projects.
- Personalized Guidance: Use personal sparring sessions to address your challenges and needs.
Don't miss out on this opportunity to elevate your health tech innovations. Secure your spot today and take the first step towards mastering health tech regulations, quality management, and commercialization.
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