Medical Device Technology – Expert Consulting and Practical Support

The development and manufacturing of medical devices requires the highest levels of precision, safety, and regulatory compliance. Melster Consulting GmbH supports medical technology companies throughout the entire process — from initial planning to successful certification — by helping them meet complex requirements and comply with all relevant standards and regulations.

Challenges in the Medical Technology Sector

The medical technology industry faces unique challenges: strict regulatory requirements, demanding development processes, and the need to meet the highest safety and quality standards. Melster Consulting understands the specific needs of the industry and provides targeted support to help you implement your projects efficiently and in compliance with applicable norms.

Our Services for Your Medical Device Project

• Consulting on Regulatory and Standards Compliance
  Guidance on compliance with the Medical Device Regulation (MDR) and relevant international standards such as IEC 62304 and ISO 14971.
• Coaching and Process Optimization
  Support in implementing development processes, risk management, software lifecycle management, and cybersecurity requirements – tailored to your organization.
• Software Development for Medical Devices
  Consulting on safe and efficient development of medical device software in accordance with IEC 62304, including risk and security management.
• Audit Preparation and Certification Support
  Preparation for regulatory submissions and conformity assessments, support during audits, and assistance in creating all required documentation.
• Training and Workshops
  Practical workshops and seminars on standards, regulatory requirements, and best practices in medical technology.

Contact

For individual consulting or project-specific support, Melster Consulting is happy to assist you. Feel free to contact us to discuss your requirements:
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Melster Consulting GmbH looks forward to supporting you reliably and competently in your medical device projects!

We adapt to your individual needs in order to offer tailor-made support in the implementation of Automotive SPICE®.