Browse Our Services
service of Medical Technology
- Neuromuscular Control Test, balance exercises equipment
- Robotic and non-robotic Hand Rehabilitation ( Functional Exercises, Weight Compensation,Action-Observation Therapy, Virtual Reality,Assessment of Performance)
- System for improving finger motor skills/relaxing and strengthening the arm muscles
- Robotic and non-robotic Gait Training System
- Wearable devices
- Installation and De-Installation of equipment
- Providing on-site trouble shooting, repairs
- SW and HW upgrades
- Spare parts storage, shipping and receiving
- Remote technical support via internet and phone
- Preventive Maintenance
- Training customers to operate the equipment
Our vast experience in the Regulatory and Quality Assurance fields will assist you in complying with international standards as well as meeting the requirements of worldwide regulatory organizations, such as the FDA and European Union ( CE Mark).
The services we provide will both allow you to begin marketing your product and ensure that you remain in compliance.
MTS360 LLC provides effective Global Regulatory Affairs services for
all stages of medical device product development and lifecycle
- Strategic Regulatory Consulting.
- FDA 510(k), PMA.
- Listing and registration with the FDA.
- EU CE Mark activities
- Liaison with FDA, Notified Bodies, Registration Bodies and Competent Authorities.
- Submission and registration of products in the Far East, Oceania, Israel, South America and other non-EU countries.
- U.S. Agent services provided by our partner company.
- EU Authorized Representative services.
- Development of product-related Regulatory Plans and Product
- Verification and Validation.
- Implementation of technical aspects of both Standards and Testing as well as certification issues.
- Investigation and reporting of incidents and adverse events.
- Mock and internal Audits (FDA QSR, EU AIMD/MDD/IVD, ISO 13485, EN 13485 etc.).
- Handling Risk Management processes in accordance with EN ISO 14971
- Information Security Management Systems (ISMS) consultancy services based on ISO 27001 and ISO 27799
- ISO 9001