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
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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
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