As soon as companies (from startups to corporates) start developing a medical device, they must start thinking about their regulatory strategy, implementing a quality management system and gathering clinical evidence data for their device.

Being innovative requires a lot of specific technological expertise of these companies. However, to make sure that a medical device becomes a success and improves people’s lives, these technical challenges are accompanied by hurdles like compliance with applicable regulations.

The MDR (Medical Device Regulations) must ensure that all medical devices on the European market comply with the applicable regulations and thereby, that the devices’ safety and performance have been demonstrated. The CE-mark on medical devices is the formal declaration that the product complies with the applicable European MDR legislation.

In order to be successful in developing a medical device, a company needs a lot of partners in every phase of the development. The Health Tech sector consists of a mix of OEMS, suppliers, SMEs, and scale-, startups, research-, educational institutes and patent / IP and medical regulatory professionals.

A large number of companies and organizations in Brainport Eindhoven is working on medical technologies, and therefor this region is an excellent entrance and stepping stone into the European medtech

Because of this, the vibrant Brainport Eindhoven is the ideal location for this conference where innovation meets regulation . Not only you will have the opportunity to hear about the latest developments in technology and legislation, but you will also be able to network personally with all relevant parties en build important relationships.

The topics of the conference are related to interaction between innovation / regulation of:

• Medical Devices
• Instrumentation
• Consumables
• Software
• Data Driven Health Care
• Health Care Platforms

Who should attend?
As this conference forms a bridge between innovation and regulations in the MedTech field, it applies to developers of medical instrumentation, -devices and -consumables:

• Product Developers / Researchers
• Engineers
• Doctors / Nurses / Medical Engineers
• Project Managers
• Product Managers
• Business Developers
• Legal professionals
• Regulatory institutions
• Certification bodies
• Investors
• Start-ups

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