ISO 13485 Management System Implementation

What are the benefits of implementing the ISO 13485 Standard?

The ISO 13485 Standard was developed to be the vehicle for global alignment of Quality Management Systems to the Medical Devices industry.

Organizations that implement a Quality Management System according to the requirements of ISO 13485 will find the following benefits:

  • Comply with regulatory requirements.
  • Providing safe and effective products.
  • Effectively manage risks.
  • Positioning of the company and access to new markets.

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CE Mark in Medical Devices

Why is it important to obtain the CE Mark for your Medical Devices?

The CE Mark on a product indicates that it complies with all the requirements of the applicable European Directives.

Obtaining the CE Mark allows your company to freely commercialize the product in the European Community and other countries of the world that are accepting it within their regulations.

The CE Mark is also a key tool for expanding your business, you can access highly regulated markets and market your products worldwide.

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Medical Device Management Consultancy

How can we help you implement Medical Device Management?

The team of professional and experienced consultants at Quara Consulting & Training has over 10 years of proven experience in implementing Management Systems and obtaining the CE Marking in Medical Devices.

We are suppliers of the UNFPA since 2011 in Quality Assurance in the procurement process of medical devices worldwide.

We have performed consulting and implemented ISO 13485 Medical Device Management Systems in different medical device companies in various countries of Latin America, Europe and Africa.

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Contact us and request more insights on our transition to ISO 9001:2015 & ISO 14001:2015 services.

Management Consulting

Our personalized consulting service, adapted to meet your business needs and objectives:

ISO 9001:2015

Quality Management

"Quality is not an action, it's a habit"

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ISO 39001:2012

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ISO 14001:2015

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"A healthy ecology is the basis for a healthy economy"

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ISO 13485:2016

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"Providing secure and effective devices is an obligation"

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ISO 37001:2016

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"The business will not be successful, if the society fails"

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ISO/IEC 27001:2005

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