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TAJANA VASILIC

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What is considered by QMS planning in ISO 13485 – Lesson 5

What is considered by QMS planning in ISO 13485 – Lesson 5

This part of the standard explains why is planning so influential. Because without planning it's impossible to build quality into your medical device and company since the start. It's necessary to plan in such a way to ensure your QMS will be and remain effective. One of the ways you can assure that is through...
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What are the Management Responsibilities according to ISO 13485 – Lesson 4

What are the Management Responsibilities according to ISO 13485 – Lesson 4

Management has an absolute responsibility to foster the quality policy, confirm its alignment, and communicates the mission to employees. They have a responsibility to plan, delegate authority, and communicate effectively. They are also in charge of a periodic review of operations and improvement within the organization, known as the Management review.   Management Commitment Some of the management...
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What are the General requirements in ISO 13485 – Lesson 2

What are the General requirements in ISO 13485 – Lesson 2

Every ISO standard has the system of requirements and each one of them is described in segments. In general requirements, it’s established what is meant by: Developing and documenting QMS – Establish QMS Defining your QMS processes – Clarify the structure Supporting them – Support processes Managing QMS process changes – Manage changes Controlling your QMS outsourcing – Control outsourcing Validating your...
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Understand ISO 13485 - Lesson 1

Understand ISO 13485 - Lesson 1

Let’s say you have an idea of placing an innovative medical device on the market. That’s great, but you already know that going from idea to actual realization is not the whole picture, just the tip of the iceberg. Yes, there is a much larger part below the surface to know about, and it has...
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5 FAQs about ISO 13485

5 FAQs about ISO 13485

1. What is an ISO 13485? ISO 13485 is an international standard for establishing quality management in the medical device industry. It is an effective explanation to meet the comprehensive requirements for a QMS in the medical device industry. The other well-known QMS requirements to follow come from the US, as the FDA requires that the medical...
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