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Welcome to MEDTECH GLOBAL®
MEDTECH GLOBAL® SERVICES
It is critical to understand product needs and requirements from the earliest product development stages.
MEDTECH GLOBAL® helps investors, technology managers and product developers taking the right decisions .
MEDTECH GLOBAL CONSULTING
MEDTECH GLOBAL ®
MEDTECH GLOBAL ® provides MEDICAL TECHNOLOGY expert consultancy for GLOBAL markets.
MEDTECH GLOBAL® 3 CONSULTANCY STAGES ADAPT TO CLIENTS NEEDS:
1- MEDTECH GLOBAL ® Pre-Assessment (*Free)
- Intensive initial Data collection
- MTG Free Pre- Assessment
2- MEDTECH GLOBAL ® Gap Analysis:
- Current State vs Requirements.
- Process Optimisation elements.
3- MEDTECH GLOBAL ® Implementation
-Plan
-Do
-Check
-Act
Production. Quality. Compliance. Product Safety.
Medical Devices REGULATORY AFFAIRS : European Union
CE Marking
CE marking is mandatory for medical devices, allowing your technology to be placed on the market in any European Union member state. There are procedural steps for CE marking, such as fulfillment of technical conditions and requirements for safety and functionality.
Quality and Risk Management Systems
ISO 13485 for Quality Management Systems and ISO 14971 for Risk Management are harmonized standards aligned with European regulatory and product safety requirements.
Post Market Surveillance Systems
Post Market Surveillance implementation throughout the medical device lifecycle with outputs to Quality and Risk Management Systems.
Conformity Review
Technical Conformity reviews for products, systems and documents. Regulatory expertise assessment for compliance with EU MDR and IVDR regulatory requirements.
IFU, Labelling and Packaging
Instructions for Use (IFU), Labelling and Packaging requirements are key elements in product regulatory compliance and subject to specific country regulations.
Audits
It is mandatory to conduct audits at planned intervals. Auditing is a systematic, independent and documented process for obtaining evidence to determine the extent to which the Medical Devices Quality Systems and Regulatory requirements are fulfilled.
Medical Devices REGULATORY AFFAIRS: UNITED STATES
U.S. Market
MEDTECH GLOBAL® works in tandem with American Regulatory Affairs consultants. US marketing rights are achieved after FDA successful submission. The most common FDA submissions are 510(k) premarket notification, PMA premarket authorization and De Novo submission. Other submissions to FDA include Pre-submissions, Investigational Device Exemptions , Humanitarian Device Exemptions , , and Master Files.