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Regulatory Affairs and QM

D.med Technologies provides tailored regulatory and quality solutions for medical device companies. One of our main assets is our own cutting-edge polyclinic. This unique advantage sets us apart, offering you an integrated approach to regulatory and quality management.

Whether you’re launching a new product or need support for an existing device, our experienced regulatory and quality management team from D.med Consulting will ensure your success across following areas:

OUR SERVICES

Market Access Strategies for EU and ROW
  • Implementation of robust approval strategies ensuring compliance with CE and FDA regulations.
  • Creation and maintenance of meticulous technical documentation to support regulatory submissions.
  • Seamless transition of product registration from MDD to MDR, covering both active medical devices and software.
  • Expertise in crafting EU and US Market Access strategies for both active and non-active medical devices.
  • Swift and effective product adaptations to meet evolving regulatory requirements.
  • Proactive post-market surveillance to ensure ongoing compliance and product safety.

International Regulatory Expertise

Navigate the complexities of global markets with our international regulatory services covering key regions:
  • APAC / ASEAN: Singapore, Taiwan, Australia, South Korea, Malaysia
  • EMEA: UK, Saudi Arabia, UAE, Nigeria, Morocco, Algeria
  • LA: Brazil, Mexico, Canada

Regulatory Affairs – Medical

Clinical investigation of medical devices from creation of documentation to execution.
  • Clinical data management
  • Clinical evaluation CEP/CER
  • Clinical investigation from creation to execution
  • Feasibility studies 
  • PMCF - post market clinical follow up
  • PMS - post market surveillance

Quality Management (QM) Consultancy

Ensure the highest standards in quality management with our dedicated QM consultancy services:
  • QM Systems Setup
    Establishing QM systems aligned with ISO 13485.
  • Audits
    Conducting internal or supplier audits to uphold quality standards.

Cybersecurity Integration

Safeguard your medical devices with our expertise in combining cybersecurity with both medical and development processes:
  • Cybersecurity + Medical
    Implementing robust cybersecurity measures for medical devices.
  • Cybersecurity + Development
    Integrating cybersecurity seamlessly into the development lifecycle.

The D.med Technologies Advantage

The D.med Advantage

Contact us

Curious to explore how we can collaborate on your ongoing or upcoming
medical device design project? Simply complete the form, and we'll reach
out to you soon!