CMG MedDev S.L.
Contact information
- Biomarkers
- Cell cultures
- In vitro diagnostics
- Diagnostic imaging
- Medical devices
- Screening
- Cardiovascular diseases and circulatory system
- Genetic and rare diseases
- Infectious diseases
- Inflammatory diseases
- Immunology
- Oncology
- Central nervous system
- Respiratory and pulmonary system
- Biotechnolgy kits
- Consultancy
- Training and spreading
At CMG MedDev, we believe in the power of customised project solutions applied to medical devices, in vitro diagnostics, software and AI. With a focus on product safety and efficiency as well as the needs of our customers at the core of our mission, we are dedicated to making your path from idea to market easier.
Our team of experts works closely with our clients to navigate the intricate regulatory landscape of MDR/IVDR, quality system and product research/clinical studies.
We go beyond simple consulting, fostering a personal connection with our clients, their products and their needs, ensuring that their objectives are met. Our results-oriented methodology is designed to deliver tangible solutions, providing a roadmap for success at every stage of your project.
From concept to commercialisation and post-market follow-up, we prioritise product safety and efficacy, always keeping our approach aligned with your needs and risk analysis, especially with regard to timelines, leveraging our industry knowledge and technical prowess to drive your innovation.
At CMG MedDev, the success of your products is our priority.
- Consultancy. On regulatory strategy, aspects of clinical studies and research, market access, development of management systems, product classification, performance evolution, market comparison/differences, biocompatibility, etc.
- Document development. Product and project roadmap, QMS, technical documentation (TD), preparation of documentation for study of clinical research applications to the competent authority and CEIM; biocompatibility assessment plan and reports, application for health license, etc.
- Technical support. Support in the pre-clinical phase, identificacation of studies or test to be carried out, including functional, mechanical, electrical, etc.; software verification/validation, sizing of studies, preparation of process validation plan and reports (including sterilisation), product usability, interpretation of sectoral standards and definition of specific actions based on them.
- Training. Development and delivery of courses on application regulations, QMS, product-specific standars suchs as SW, risk analysis, usability, cubersecurity, research or clinical studies, scientific, analytical or clinical evalutation. They can be delivered for organisations or general.
- Additional services.
- Implementation of other QMS such as ISO 15189, ISO 17025 or ISO 20387.
- Co-development of CIP, and all other documentation required for clinical studies or investigations.
- In Vitro Diagnostics (IVD)
- Companion diagnostic CDx
- Personalised medicine
- Next-Generation Sequencing NGS
- Medical device / Medical device
- Software as medical device
- Software as IVD
- Artificial Intelligence
- Performance studies with IVD products
- Clinical research with medical devices
- Coronary stents
- Orthopaedic implants
- Implantology and Digital Dentistry
- ISO 13485:2016
- ISO 14971:2019
- ISO 14155:2020
- ISO 20916:2019
- ISO 15189