Mtech Group
Mtech Group is a regulatory consulting company specializing in medical device and cosmetic industry compliance. They assist clients with establishment registration, device listing, regulatory clearance, and act as US agents for FDA communications. Their team includes experts in medical applications, device development, FDA regulations, and quality control, providing personalized consulting to navigate complex medical device regulations and market entry in North America.
Industries
Nr. of Employees
small (1-50)
Mtech Group
Houston, Texas, United States, North America
Services
End-to-end preparation and submission of traditional, special, and abbreviated 510(k) premarket notifications to regulatory authorities.
Management of establishment registration and device listings in regulatory agency systems, including renewal tracking and notifications.
Acting as an official correspondent for foreign establishments to assist regulatory agencies with communications, responses, and inspection coordination.
Audits of QMS procedures and production controls to assess regulatory compliance and identify corrective actions.
Design and execution of human factors analyses and validation tests, including task scenarios, participant recruitment, objective and subjective data collection, and result analysis to support regulatory submissions.
Support for clinical trial planning and operations, including use and integration of eClinical platforms to streamline trial workflows across phases.
End-to-end preparation and submission of traditional, special, and abbreviated 510(k) premarket notifications to regulatory authorities.
Management of establishment registration and device listings in regulatory agency systems, including renewal tracking and notifications.
Acting as an official correspondent for foreign establishments to assist regulatory agencies with communications, responses, and inspection coordination.
Audits of QMS procedures and production controls to assess regulatory compliance and identify corrective actions.
Design and execution of human factors analyses and validation tests, including task scenarios, participant recruitment, objective and subjective data collection, and result analysis to support regulatory submissions.
Support for clinical trial planning and operations, including use and integration of eClinical platforms to streamline trial workflows across phases.
Expertise Areas
- Medical device regulatory consulting
- Premarket submission strategy (510(k))
- Human factors and usability engineering
- Clinical trial operations and eClinical systems
Key Technologies
- eClinical trial management systems
- Human factors / usability testing methodologies
- Regulatory submission portals (FDA FURLS, Health Canada filing systems)
- Quality management system audit methodologies
News & Updates
Mtech Group and CRScube signed a Master Service Agreement to provide CRO service providers one total-eClinical Trial Solution. With over 1,500 clinical trial projects under its belt, all-in-one CRScube can streamline the overall clinical trial process.
Mtech Group and CRScube signed a Master Service Agreement to provide CRO service providers one total-eClinical Trial Solution. With over 1,500 clinical trial projects under its belt, all-in-one CRScube can streamline the overall clinical trial process.