Medanex Clinic
NAMSA is a global leader in medical device and IVD safety and compliance, providing comprehensive services including consulting, preclinical research, clinical trials, testing, and specialized expertise in devices such as peripheral vascular. With over 1,400 experts and extensive experience in numerous therapeutic areas, NAMSA supports manufacturers worldwide to accelerate product development and ensure regulatory compliance.
Industries
Nr. of Employees
small (1-50)
Medanex Clinic
Products
Regulatory roadmap program
A structured program providing a detailed regulatory roadmap from preclinical research through post-market compliance to reduce development delays.
E-learning courses on ISO 10993 series
On-demand and scheduled e-learning modules covering chemical characterization and biological evaluation per ISO 10993 standards.
Medical Device Preclinical Services
Preclinical medical device research services to evaluate product or device safety and performance with GLP-compliant studies using small and large preclinical models.
Imaging Core Lab
Preclinical imaging core lab providing end-to-end imaging support with advanced modalities like CT, MRI, micro-CT, ultrasound, and intravascular imaging for medical device development.
GLP Preclinical Research Studies
GLP-compliant preclinical research studies on a wide array of medical devices with cutting-edge equipment and techniques including digital catheterization labs with Fixed C-arm platforms.
Preclinical Pathology Services
High volume pathology labs with histopathology and SEM/TEM laboratories, operated by qualified histotechnicians and Board-Certified pathologists for tissue and device collection and evaluation.
Regulatory roadmap program
A structured program providing a detailed regulatory roadmap from preclinical research through post-market compliance to reduce development delays.
E-learning courses on ISO 10993 series
On-demand and scheduled e-learning modules covering chemical characterization and biological evaluation per ISO 10993 standards.
Medical Device Preclinical Services
Preclinical medical device research services to evaluate product or device safety and performance with GLP-compliant studies using small and large preclinical models.
Imaging Core Lab
Preclinical imaging core lab providing end-to-end imaging support with advanced modalities like CT, MRI, micro-CT, ultrasound, and intravascular imaging for medical device development.
GLP Preclinical Research Studies
GLP-compliant preclinical research studies on a wide array of medical devices with cutting-edge equipment and techniques including digital catheterization labs with Fixed C-arm platforms.
Preclinical Pathology Services
High volume pathology labs with histopathology and SEM/TEM laboratories, operated by qualified histotechnicians and Board-Certified pathologists for tissue and device collection and evaluation.
Services
Clinical trial design and execution for medical devices and IVDs, including site initiation, monitoring, CTMS support, imaging core lab services, safety management and biostatistics.
GLP and non-GLP preclinical study design and conduct, preclinical pathology and functional/ex vivo device testing to support regulatory submissions.
In-house analytical testing including biocompatibility, microbiology, sterility, extractables & leachables and material testing performed in accredited laboratories.
Regulatory strategy development and submission support for FDA and international pathways, quality management system gap analyses, post-market planning and technical regulatory writing.
Instructor-led training, webinars and e-learning courses on biological evaluation, chemical characterization and regulatory standards (e.g., ISO 10993 series).
Centralized client portal for document exchange and project collaboration with single sign-on and multifactor authentication.
Clinical trial design and execution for medical devices and IVDs, including site initiation, monitoring, CTMS support, imaging core lab services, safety management and biostatistics.
GLP and non-GLP preclinical study design and conduct, preclinical pathology and functional/ex vivo device testing to support regulatory submissions.
In-house analytical testing including biocompatibility, microbiology, sterility, extractables & leachables and material testing performed in accredited laboratories.
Regulatory strategy development and submission support for FDA and international pathways, quality management system gap analyses, post-market planning and technical regulatory writing.
Instructor-led training, webinars and e-learning courses on biological evaluation, chemical characterization and regulatory standards (e.g., ISO 10993 series).
Centralized client portal for document exchange and project collaboration with single sign-on and multifactor authentication.
Expertise Areas
- Clinical trial management
- Clinical data management and biostatistics
- Biocompatibility and biological safety
- Medical device analytical testing
Key Technologies
- GLP-compliant animal and ex vivo models
- Biocompatibility testing (ISO 10993 series)
- Extractables and leachables chemical characterization (ISO 10993-18)
- Clinical trial management systems (CTMS) and electronic data capture (EDC)
News & Updates
A curated forum bringing together industry leaders, startups, investors, and service providers in Europe, held in September 2025 in London.
An exhibition connecting suppliers and research experts in Japan, scheduled for April 2025 in Tokyo.
A leading event for medical device and IVD regulation in Europe, scheduled for June 2025 in Berlin.
An article discussing biological testing methods for medical devices.
An overview of validation and testing for medical device packaging shelf-life.
A video explaining the functions of an imaging core lab.
A curated forum bringing together industry leaders, startups, investors, and service providers in Europe, held in September 2025 in London.
An exhibition connecting suppliers and research experts in Japan, scheduled for April 2025 in Tokyo.
A leading event for medical device and IVD regulation in Europe, scheduled for June 2025 in Berlin.
An article discussing biological testing methods for medical devices.
An overview of validation and testing for medical device packaging shelf-life.
A video explaining the functions of an imaging core lab.