QMS & Global Regulatory ServicesWe provide comprehensive product development consultancy services to medical device manufacturers, supporting the development of new products and the establishment of the quality and regulatory documentation required throughout the product lifecycle. Our services cover a broad range of medical device categories, from conventional surgical instruments and implantable devices to electrical medical equipment, diagnostic devices, software-based medical devices, and other specialized healthcare technologies.
Our approach integrates product-specific design and development activities with Quality Management System (QMS) requirements and applicable regulatory requirements.
We assist manufacturers in translating product concepts, intended purposes, user needs, and applicable safety and performance requirements into defined design inputs, technical specifications, manufacturing processes, inspection criteria, and supporting documentation.
Based on the device category, intended use, manufacturing activities, and target markets, we support the preparation and implementation of relevant QMS procedures, product-specific quality documents, design and development records, risk management documentation, verification and validation records, and regulatory technical files. This integrated approach helps manufacturers establish controlled development processes, demonstrate product conformity, and prepare for applicable certification audits and regulatory submissions.
Medical device Categories Medreg Support
- Orthopaedic and Implantable Medical Devices
- Spinal pedicle screw and rod systems
- Bone plates, screws, pins, and wires
- Orthopaedic fixation and trauma implants
- Intramedullary nails and associated instruments
- Arthroscopy implant and instruments
- Non-Active Medical Devices
- General and specialized surgical instruments
- Laparoscopic instruments, trocars, graspers, scissors, and applicators
- Wound dressings, bandages, and wound management products
- Catheters, cannulas, tubing, and drainage devices
- Infusion and administration sets
- Medical tubing, connectors, and fluid-management accessories
- Respiratory masks
- Active Non implantable Medical Devices and Electrical Medical Equipment
- Blood pressure monitor
- Medical thermometer
- Pulse oximeter
- Intensive care patient monitoring system
- Spirometers
- Patient warming system
- Sequential compression and DVT prevention devices
- Electrocardiographs
- Electroencephalographs
- Active Implantable medical devices
- Implanted defibrillator
- Spinal cord stimulator
- Implantable cardiac pacemakers
- Implantable bladder stimulators
- MRI computer tomograph
- Dental, ENT, Ophthalmic, and Specialty Medical Devices
- Dental instruments and devices
- Ear, nose, and throat (ENT) devices
- Ophthalmic instruments and medical devices
- Endoscopic and minimally invasive surgical devices
- Medical Device Accessories and Reusable Products
- Reusable surgical instruments
- Device-specific accessories
- Medical device components and compatible connection systems
- Reusable products requiring validated cleaning, disinfection, and, where applicable, sterilization
