ISO 13485:2016
Medical Devices

ISO 13485 provides proof that your company delivers safe and effective medical devices


ISO 13485 is the international standard relating to Quality Management Systems for organizations involved in the manufacture of medical devices, including active medical devices, active implanted medical devices, sterile medical devices and others. It is directed towards any business dedicated to improving the way it’s operated and managed. It is based on ISO 9001, but it removes 9001’s emphasis on continual improvement and customer satisfaction, and instead emphasizes meeting regulatory as well as customer requirements, risk management and maintaining effective processes.

The tangible benefits of implementing ISO 13485 will give your company a competitive edge and increased opportunities. So it’s no wonder its adoption is growing in popularity.

Show your Company’s Commitment to Continual Improvement and Customer Satisfaction

Your company can use ISO 13485 for the design, development, production, installation and servicing of medical devices. It shows your commitment to quality, customers and improving efficiency. Because certification is only given when your company can demonstrate compliance to the safety, regulatory and quality concerns specific to the medical-device industry measured through an external audit, your company image will be enhanced in the eyes of customers, employee and shareholders.

To explore how IMSM can guide you through the entire certification process, visit Making ISO Simple today.

Gain An Edge Over Your Competitors

Your company will benefit in a myriad of ways with ISO 13485 certification that include:

  • Helps motivate staff and outline clear roles and key responsibilities
  • Provides your company can consistently meet customer requirements and comply with regulatory requirements and safety standards
  • Increase efficiency and productivity, and minimizes cost
  • Monitor supply chain performance
  • Reduces waste, inappropriate or rejected work and complaints
  • Incorporates regulatory requirements impacting the product itself and its technical features throughout the design and development process
  • Brings together a comprehensive approach to the medical device lifecycle – its packaging, labeling, installation, servicing and usability
  • Increases customer satisfaction by delivering products with the consistent quality they expect

To learn more about what ISO 13485 certification will do for your company, contact IMSM today.

Getting Started

As a medical devices manufacturer, you have a responsibility and requirement to consistently deliver devices that are high-quality, safe and effective. There is no better time than today to start, and IMSM will help you every step along the way.

IMSM will guide your business as you:

  • Identify the requirements of ISO 13485 and how they apply to your business
  • Establish quality objectives and determine how they best fit in to your business operation
  • Produce a documented quality policy outlining how your business will satisfy the requirements
  • Communicate the requirements throughout the company
  • Evaluate the quality policy, including its objectives, and then prioritize the requirements to ensure they’re met
  • Identify the boundaries of the management system and develop documented procedures
  • Undertake internal audits to make sure the management system continues meeting your business needs

To schedule a no-obligation consultation, contact IMSM today.

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