Doctor with advanced equipment in hospital ward.; Shutterstock ID 437274070; purchase_order:Kampagne

ISO13485:2016 Hybrid Training

Language : English

Please choose a date from the options below					Please choose a date from the options below	Location	Price
On demand Virtual Instructor Lead (VILT) 8800 Rand (ZAR)	Virtual Instructor Lead (VILT)	8800 Rand (ZAR)	Book

# ISO 13485

The international standard ISO 13485 forms the basis for the certification of quality management systems in companies that manufacture or distribute medical devices - or that are involved in their manufacture as part of the supply chain.

In terms of content, it addresses the requirements that medical device manufacturers and suppliers must meet in developing, implementing and maintaining management systems for the medical device industry

Target

Upon completion of this course, delegates will be able to:

Explain the scope and structure of ISO 13485:2016
Describe the requirements of the Standard
Interpret the requirements of the standard within an organisation
Identify systems and processes that are required to implement the Standard
Established and maintain the Standard within an organisation
Achieve and maintain certification with the Standard

Agenda

Content

ISO13485:2016 demonstrates your ability to provide medical devices and services that consistently meet Customer, Regulator and ISO13485 Requirements:

Understand Regulatory Requirements
Understand the Requirements and Structure of ISO 13485
Interpret and Apply these requirements
Evaluate company requirements
Implement ISO 13485:2016 (The Standard)

Auditors

DQS South Africa

Moderator

In everything we do, we set the highest standards for quality and competence on every project. As a result, our actions become the benchmark for our industry but also our own guiding principle, which we renew every day.