Medreg provide end-to-end consultancy services for establishing, developing, and strengthening medical device manufacturing operations. Our turnkey projects cover facility planning for new manufacturer, Quality Management System (QMS) implementation, guidance for manufacturing process development, quality control systems, product technical documentation, and regulatory submission support.

We work closely with medical device manufacturers to establish the infrastructure, documented processes, technical files, and quality controls required for manufacturing medical devices in accordance with applicable regulatory requirements and recognized standards, including ISO 13485, ISO 14971, and relevant product-specific standards.

Our objective is to provide manufacturers with a structured consultancy pathway from initial project planning to manufacturing and QMS readiness, supporting product quality, regulatory compliance, and preparation for certification and market entry in their intended markets.

It is based on the device type, manufacturing activities, intended markets, and applicable regulatory requirements, includes below services:

Medical Device Manufacturing Facility Setup
Guidance on infrastructure requirements
Guidance on environmental control requirements
Ensuring maintenance activities
Guidance on validating special processes
Establishment of purchasing specifications and quality requirements for raw materials, components, and outsourced services
Implementation of Medical device Quality Management System
Documentation for design and development
Assist in Risk Management File preparation
Product technical documentation and regulatory submission support
Support for selection of notified body/Auditing organization
Sterilization support
Guidance on Stability study
Providing Support for Internal audit and External audit readiness