HeiMed

Since 2006, we provide high-quality services for the medical device industry in order to support our customers in dealing with constantly growing regulatory requirements:

• Clinical Evaluations
• Medical Device Regulation (MDR)
• Post-Market Surveillance (PMS)
• Post-Market Clinical Follow-up (PMCF)
• Biological Evaluations
• Risk management
• Technical documentation
• CE marking of medical devices

With foresight, we are constantly adapting our services to prepare our customers individually and optimally for new requirements. Currently, we have expanded our product portfolio to include services related to the implementation of the requirements of the Medical Device Regulation MDR. It is accompanied by another key topic of MDR, the Post-Market Surveillance (PMS) service package. The usual services clinical evaluations, biological evaluations, risk management, preparation and maintenance technical documentation and the support in CE certification are of course still available. To cover special challenges in MDR, we have partially extended them in order to identify possible problems in advance and to make appropriate preparations at an early stage. Since this strongly depends on the individual products, we were only able to address some of them in the presentation of our service packages. Contact us to determine your individual requirements.

We provide customized solutions, adapted to your needs, your products, possible OEM/PLM constellations and your target markets. Our outsourcing solutions are designed in a way that you can easily and reliably complement the competencies in your company.

Would you like more information? We are pleased if you visit our website.

Company’s Keywords:

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