ISO 13485

ISO 13485

It is important that manufacturers of medical devices show that they have implemented and are maintaining a quality system for their products. ISO 13485 is the quality management standard written specifically for medical device manufacturers. Based on the ISO 9001 standard, complying with ISO 13485 ensures that requirements for quality are met. Countries in Europe and South America, and also Japan and Canada recognize ISO 13485 as applying best quality practices within the medical device industry; so ultimately, registering to ISO 13485 can increase your market potential around the world.

ISO 13485

ISO 13485 is comprised of additional requirements specific to the medical device industry for areas such as design, development, production, and environmental control. Then through auditing, you continuously benchmark your products against the standards and make adjustments, as needed, to ensure that your products consistently meet standards and customer needs.

Approach

Georgia Tech will come to your site and train your team, providing you with the tools necessary to become ISO 13485-registered. We will:

  • Conduct a gap audit and help you develop an implementation plan
  • Coach your team through QMS implementation
  • Assist with the initial internal audits and management reviews
  • Conduct a pre-assessment audit
  • Help you correct system issues before the registration audit

Earning ISO 13485 registration will help you:

  • Maintain a homogenous and consistent quality system
  • Establish measurable objectives
  • Regularly audit, evaluate, and adjust your systems to conform to international requirements
  • Gain customer confidence in your products or service
  • Gain entrance into world markets

In addition to project work, you can either enroll yourself or an employee in our open-enrollment course, Understanding ISO 13485: Quality Management for Medical Devices, or we can come to your site and train your team.

Benefits

Upon implementing a quality management system, your company will:

  • Improve quality
  • Improve efficiency and productivity
  • Meet customer and regulatory demands and expectations
  • Increase customer satisfaction and retention
  • Reduce risk of regulatory violations

Related Standards and Regulations

Georgia Tech offers implementation assistance for the following complementary standards and regulations:

  • US FDA Medical Device Quality Systems Regulation 21 CFR 820
  • ISO 14971 Medical Device – Application of risk management to medical devices
  • SOR-98-282 Canadian MDR (Medical Device Regulation)
  • The European Medical Device Direction MDD-93-42-EEC as amended by 2007-47-ECA

QMS is maintained through the diligent effort and knowledge of the organizations human resources. Georgia Tech offers the following related services to help organizations effectively develop its human talent:

  • Executive Overview of ISO 13485
  • Employee training ISO 13485
  • Internal Audit Training
  • Lead Auditor Training
  • 21 CFR 820 Regulation Training
  • Customized training for specific needs

Contact Us

If you are interested in finding out more about ISO 13485 or training your team, contact Tim Israel or the regional manager in your area.

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