Specialized CRO for regulatory consulting, quality assurance, and clinical trials in the MedTech sector
1MED
New on Amplifa
About 1MED
1MED is a Contract Research Organization (CRO) specializing in medical technology and combination products, not a manufacturer. The company supports MedTech manufacturers throughout the entire product lifecycle: regulatory consulting under EU-MDR/IVDR and FDA, establishment and maintenance of Quality Management Systems according to ISO 13485, planning and execution of clinical trials, biometrics, medical writing, and Post-Market Surveillance (PMS, PSUR, PMCF, Vigilance). Additionally, 1MED offers 1Survey+, a validated digital platform for collecting clinical real-world data with blockchain-based data integrity. Documented metrics include over 170 international clinical trials supported, over 500 CE-certified medical devices, and more than 300 successfully completed certifications. Location details, history, and company metrics such as founding year, number of employees, or export rate are not published in the accessible sources; the internal quality assurance is certified according to ISO 13485.
- Processes
- Regulatory Services (MDR/IVDR, FDA), Quality Management System design, implementation and maintenance, Clinical trial management, Pre- and post-market trial support, Biometrics, Medical writing, Post-Market Surveillance (PMS/PSUR), Post-Market Clinical Follow-up (PMCF)
- Materials
- EU Medical Device Regulation (2017/745/746), US Approval Processes, Quality Management System Standard, GCP for Clinical Trials, Digital Data Platform
- Certificates
- ISO 13485
- Industries
- MedTech, Medical Devices, In-Vitro Diagnostics (IVD), Combination Products, Cosmetics, Combination Products
- 01
Regulatory Strategy and Classification
- 02
Technical Documentation
- 03
Clinical Evaluation and Trials
- 04
Certification / CE Marking
- 05
Post-Market Surveillance and PMCF
- 06
Digital Data Platform (1Survey+)
Services and Methods
EU Medical Device Regulation (2017/745/746)
Regulatory consulting, gap analyses, and technical documentation for medical devices and IVDs.
US Approval Processes
Support for 510(k), PMA, IDE, IND, Q-Sub, and Breakthrough Designation.
Quality Management System Standard
Design, implementation, and maintenance of certifiable QMS.
GCP for Clinical Trials
Methodological framework for clinical trials and PMCF data collection.
Digital Data Platform
Validated platform for PMCF, PMS, and Real-World Evidence with Blockchain validation and AI quality monitoring.
Services
Inside the production
Industries
Additional services
Quality and Certification
1MED itself is certified according to ISO 13485 as a company and conducts internal audits, supplier audits, and Notified Body audits for customers.
| Evidence | Company |
|---|---|
| ISO 13485 |