ISO 13485 Benefits of Certification

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For manufacturers of medical devices who want to provide safe/effective equipment,   a proper Quality Management System (QMS) needs to be in place in order to comply with regulatory requirements.  Since 2003 when ISO 13485 was first implemented and recognized by the Global  Harmonization Task Force (GHTF),  it has quickly become the model standard for the medical industry. 

By becoming certified in the ISO 13485 standard your company will:

  • Increase the probability of making safe and effective medical devices
  • Meet regulatory requirements
  • Meet customer expectations
  • Help monitor the effectiveness of your supply chain

 This standard is recognized by most major markets around the world (United States of America, Europe, Canada, Japan, and Australia) and more major markets are likely to adopt this standard.  With ISO 13485 certification you will be able to enter any major market around the world with one audit!
By becoming ISO 13485 certified your company’s Quality Management System (QMS) will be in line with the Food and Drug Administration’s (FDA) QSR standards.

Additional Benefits of ISO 13485 certification:

  • Increased Efficiency
  • Cost Savings
  • More Effective Risk Management and Quality Assurance
  • Improved ability to respond to Customer Requirements

Choose SQA today for your ISO 13485 Certification!  Our knowledgeable and accredited Registrars will help make your certification process smooth from start to finish.  By choosing a reputable company such as SQA your customers will realize the commitment your business is making to produce the highest quality, safe, and effective medical devices on the market.

Choose SQA as your ISO 9000 for Healthcare Registrar today.

A representative from SQA would like to discuss your certification needs. Contact us at 330-762-4231 today.