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Whether data protection, quality assurance, marketing or compliance: In a heavily regulated environment, medical technology companies are confronted with legal issues every day. The abundance of topics and underlying laws and regulations makes it increasingly difficult to get an overview of the rights, obligations and consequences. The course closes these gaps: It conveys practical basic knowledge of the most important specialist areas, illuminates legal and contractual aspects and thus enables the participants to better assess the requirements of the company, but also their own claims against third parties, especially when they do not have any of their own legal department in the company is available. A focus is placed on aspects resulting from the EU-MDR.

target group

Managing directors, executives and those responsible who would like to acquire basic knowledge of medical technology-specific legal, contractual and compliance issues.

Topic overview & dates

03/16/2023 Contract management in a medical technology company (half-day)
03/30/2023 The General Data Protection Regulation (GDPR) in a medical technology company (half day)
04/20/2023 Medical Devices Law (European Medical Devices Ordinance (MDR), Medical Devices Implementation Act, etc.) (all day)
May 11, 2023 HealthCare Compliance (half day)
05/24/2023 The quality assurance agreement within the framework of the EU-MDR (half-day)
06/15/2023 Correct advertising under the EU-MDR and Medicines Advertising Act (half-day)
06/27/2023 Liability for medical devices (half day)
06.07.2023 Pitfalls in cross-border legal transactions (half day)
07/20/2023 Responsible person according to Art. 15 EU-MDR - between responsibility and liability

exam and graduation

After the course, the technical knowledge and skills acquired are tested in writing. Please register for the exam via our appointment calendar . After passing the exam, the participant receives a certificate issued by MedicalMountains GmbH.

Funding Opportunity

KONTAKT:
Online

 

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