MDR workshop 4: Support mechanisms and opportunities for companies on their MDR journey

Tehnopol HealthTech together with Estonian Health Insurance Fund, Estonian Health Board and Enterprize Estonia is organizing Workshop program for MDR process. The program consists of 4 workshops:

The event will be last one of the batch previous events are found here:

• 20. 03 "MDR definition, defining and ABC journey”
• 03.04 "MDR regulation, requirements and AI data act”
• 8.05 "MDR certification process, support system and companies experience”
• 15.05 “MDR support mechanisms and opportunities for companies regarding their MDR journey.”

Fourth workshop on "Support mechanisms and opportunities for companies in their MDR journey", will be a hybrid event on the 15th of May 14.00-17.00 at Science and business park Tehnopol, address Akadeemia tee 21/1, room Veenus.

Please register for the event, even if you plan to join online, so we can share the link with you.

The main aim about the fourth workshop is to introduce the opportunities the sector is offering on an international level and how to collaborate with different parties. The aim of the panel discussion is to provide best practices from companies and experts during their MDR journey and showcase their innovation.

Agenda:
13.45-14.00 Registration
14.00 – 14.20 Support from public sector in MDR process – overview by the Estonian government innovation lab (Greta Elva-Jõemaa, Head of Public Policy and innovation at Accelerate Estonia)
14.20-14.35 Support mechanisms through Applied Research program by Enterprize Estonia (Reet Reinart-Okugbeni, EIS R&D expert)
14.35-14.50 Innovation Support Opportunities (Kristin Kuusk innovation specialist at Estonian Health Insurance Fund)
14.50-15.30 Overview of support programs for MDR – best practices and recommendations for companies applying for the CE marking (Fabrizio Giannotta, MDR expert, WSL incubator, Belgium)
15.30-15.45 Coffee Break
15.45-16.30 How to provide accurate information and support for companies applying for MDR?

• WSL incubator, TRL booster program (Belgium), Fabrizio Giannotta
• Softneta (Laura Baroniene, quality manager and external auditor of Lithuanian medtech companies)
• LysMedical (Benjamin Mertens, CEO)

16.15-17.00 Conclusions and networking

Accelerate Estonia: Estonia’s governmental innovation lab, helping to remove regulatory barriers for entrepreneurs to enable their novel solutions.

Applied Research Programme – Enterprise Estonia: The programme supports the development of innovative products and allows you to grow your company’s income by developing new or significantly enhanced technologies, processes, products or services.

Innovation Fund – Estonian Health Insurance Fund: The innovation grant supports the implementation of impact studies of the developed services.

WSL Incubator – TRL Booster Program: In TRL Booster MedTech Edition (TRL-B ME) they examine ten main phases of a medical device product lifecycle which are essential in getting your product to the market quickly and efficiently.

LysMedical: Lys Medical is focused on developing new advanced endoscopic technologies to help pulmonologists provide the best care to their patients.

The aim of the workshops is to provide an overview of the journey of applying for a software medical device – at what point does software classify as a medical device; what are the necessary requirements (quality, safety, research) to ensure health protection for patients;
what competencies the team needs; how to monitor one’s activities;
what regulatory strategy and other aspects are based on the ultimate goal.

Over the course of four workshops, practical knowledge will be shared with stakeholders to support the process of applying for software medical devices, help navigate it, and provide support through networking and contacts.

The workshops for software medical devices is intended for members of the Health Technology community at Tehnopol (including former members of the Connected Health cluster), healthcare partners, representatives from the public and private sectors, industry experts, and specialists.