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.
Support in Transition MDD - MDR
- 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.
Regulatory Radar for new or changed regulatory requirements
- Swift and effective product adaptations to meet evolving regulatory requirements.
Post Market Surveillance
- 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
Unique blend of regulatory expertise and extensive own experience in developing medical devices. Our experts integrate regulatory requirements into the development lifecycle, ensuring efficiency and compliance from concept to market.
Wealth of experience in QMS Implementation and Regulatory Affairs. With a focus on compliance with MDR, FDA, and international registrations for both medical devices and In Vitro Diagnostics (IVDs), our experts ensure your products meet the highest standards globally.
Cybersecurity Mastery for Medical Devices. Our team possesses extensive knowledge of the latest cybersecurity regulations (ISO81001-5-1), ensuring that your medical devices are not only compliant but also safeguarded against evolving threats.
State-of-the-Art Clinic for Comprehensive Support. At D.med Technologies, we go beyond traditional services. Our own-state-of-the-art clinic serves as a hub for medical trials, feasibility studies, clinical evaluations, data analysis and post-market clinical follow-up. This integrated approach ensures a streamlined and comprehensive solution for every stage of your product’s life cycle.
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!
medical device design project? Simply complete the form, and we'll reach
out to you soon!
