ISO 13485 Medical Device Quality Management System

  • Fullfil customer, CE and regulatory requirements
  • Reduce the risk of medical device from design to distribution process
  • Improve the product quality
Schedule FREE 30 Mins Consultation Call

Our Clients

Let's learn...

What is ISO 13485?

ISO 13485:2016 is a management system for medical device. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

Medical Device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:

a) Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease,

  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury

  • investigation, replacement, modification or support of the anatomy or of a physiological process,

  • supporting or sustaining life

  • control of conception

  • disinfection of medical devices

  • providing information for medical or diagnostic purposes by means of in-vitro examination of specimens derived from the human body;

  • and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.

What is ISO 13485 for

  • Comply with Contract requirement 
  • Enhance compliance of relevant regulation
  • Give customer more confidence. Manufacturer, Warehouse Distributor can apply ISO 13485.
Steps

ISO 13485 Consultancy Service

We established 4 different milestones for monitoring purpose and described our activities in consultancy services from zero to certification.
Phase 1

System Review

  • Understand the existing operation and documentation.
  • Identify key gap against ISO 13485 requirements.
Phase 2

Documentation

  • Establish management system framework.
  • Establish required procedures and forms
  • Conduct ISO 14791 Risk Assessment
Phase 3

ISO 13485 Implementation

  • Prepare a session of ISO 13485 awareness training
  • Prepare various records required by documentation.
  • Check the preparation via regular advisory visit
Phase 4

ISO 13485 Certification Audit

  • Liaise with Certification Body for audit arrangement.
  • Support the whole Certification Audit.
  • Provide suggestion for closing non conformity.
What we offer

Features

Saving Time & Money

No hidden cost. Completion within budget and timeframe.

Easy to follow

Straight forward & Simple ISO 13485 documentation. Minimum workload is required.

Precise Training

Precise ISO 13485 trainings to client for quick glance

Flexible schedule

Arranging meeting schedule up to Client request
Get Quote Now!
Standard

Frequent Asked Question

Clients are saying...

Testimonials

Highly recommended anyone seeking for ISO management consultancy service….
ISO 9001 Certification
Steve Smithers
COO, IBI
Professional support, Effective Training, Process smooth. Zero NC
ISO Certification Client Testimonial
Charles Wan
Founder, Revozport
…internal communication and company operation have been highly enhanced….
ISO 27701 PIMS Certification
Chris Cheng
MD, Global Switch
We are looking forward to your continuing support in maintaining the system…
ISO 9001 Consultant Gabriel Consultant Hong Kong
Keith Cheong
Executive Director , NV5
….we will plan to get more certifications through your professional service….
Brian Cha
Founder, Brian Cha Motivation
…..they gave us full support and professional guidance …..
May Chan
QA Manager, Ocean Park

Get your free copy

ISO Certification Guide 2024

The Guide will show you
  • 8 Steps – a road map to ISO Certification
  • Which ISO Certification fit your company
  • How to select Consultant and Certification Body
1
Register
2
Submit

Let the Numbers Speak

330+

Happy Clients

450+

Successful Projects

98+

Satisfaction Level

Our Consultant Team

Committed to providing quality consultancy services.

Lotto Lo

Senior Consultant

Pauline Lin

Senior Consultant

Latest Posts

ISO logo UKAS SGS
Gabriel Consultant in ISO Consulting
Service with 20 years of experience.
Find Us
© 2024 Gabriel Consultant. All rights reserved
Find Us
© 2024 Gabriel Consultant. All rights reserved
Standard

Office Hour: 9:00- 18:00

Tel : +852 23664622

Email : info@gabriel.hk

Free 30 Min Consultation Call

Request an economy and speedy way to get an ISO Certification