Medical & Healthcare Devices

AA+A++
HKPC

 

 

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Medical & Healthcare Devices

Medical & Healthcare Devices

 

Introduction

With intense competition in traditional industries, many Hong Kong manufacturers are now looking for new investment opportunities, such as entry into the emerging medical and healthcare device industry. This market is potentially lucrative but also presents challenges. Products must comply with stringent international regulations and quality system requirements. Knowledge of the latest production processes and technologies is also required of manufacturers.

To help the industry rise to these challenges, HKPC provides a comprehensive range of consultancy and support services specifically designed for the sector. These services cover: 

Medical Engineering Technology

  • Medical System Application and Customization (e.g. Remote Patient Monitoring, Telemedicine)
  • Bio-signal / Physiological Signal Processing (e.g. Cardio-electro-signal)
  • Sensor and MEMS Technology (e.g. Blood Glucose Testing)
  • Medical Material Technology (e.g. Orthopaedics, Gynecology, Implantable Device)
  • Anti-bacterial and Surface Treatment Technology (e.g. Metal Surface Anti-bacterial)
  • Surface Treatment Technology Advanced Sterilization / Disinfection Technology (e.g. Plasma, Ozone)
  • IT Technology and RFID Technology

 

Medical Device Regulatory Support

  • USA FDA Pre-market Notification (510K) Application
  • EU Medical Device CE-Marking (Medical Device Directive)
  • Medical Device Good Manufacturing Practice (GMP / QSR)
  • Medical Device Manufacturing Quality System in Accordance with ISO13485
  • Risk Management for Medical Device Manufacturing in Accordance with ISO14971
  • Hong Kong Medical Device Administrative Control System
  • Process Validation and Risk Assessment
  • Medical Device Traceability and Recall Procedure

 

Product Development and Testing

  • Medical Electronics Safety Assessment in Accordance with IEC60601-1 (e.g. Electrical Safety, Mechanical Safety)
  • Medical Device Development and Design Control
  • Design Safety Evaluation
  • Product Performance Evaluation
  • Medical Grade Material Evaluation
  • Finite Element Analysis (FEA)
  • Product Failure Analysis
  • Sterilization / Disinfection Performance Evaluation
  • Microbiological Tests (e.g. Microbial Enumeration in Food, Medical Device and Cosmetic Product)

 

Manufacturing Technology and Environment

  • Critical Cleaning
  • Cleanroom Planning and Project Management
  • Powder Injection Moulding
  • Critical Component Pilot Production (Metal / Ceramic)

 

Click here to download the pamphlet on services for this industry.

 

Contact:

Ir Bryan SO
Tel: (852) 2788 5548
Fax: (852) 2788 6338
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

 

Click here for enquiry.