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ISO 13485 and MDR Internal Auditor

  • Location

    Helsinki, Finland

  • Start

    11. Mar 2025

    9:00 AM

  • End

    12. Mar 2025

    5:00 PM

  • Time Zone

    Helsinki, Kyiv, Riga, Sofia, Tallinn, Vilnius (+02:00)

Register Now

SGS Academy in Finland will organize a training

ISO 13485 and MDR Internal Auditor (2 days)

Date and location:

March 11th – 12th, 2025

9 am – 5 pm on both days (Registration and breakfast starting 8.40 am)

Juju Kampus, Takomotie 8, 00380 Helsinki

Introduction:

This course is designed to familiarize quality and regulatory professionals, engineers, designers and management with the requirements for internal auditing of ISO 13485 quality systems. The objective of this course is to provide the skills and knowledge required to conduct internal audits as required by ISO 13485 and Medical Device Regulation. Upon completion of this course delegates will:

  • Understand the requirements of ISO 13485:2016, and the quality system requirements of Directives 93/42/EEC and 98/79/EC
  • Know how to conduct internal quality system audits

They will be able to:

  • understand the role of internal audit in the maintenance and improvement of management systems
  • plan and prepare for an internal audit
  • learn to gather evidence by observation, questioning & sampling
  • write factual reports on the compliance of the management system against the audit standards
  • participate in the corrective action process

The training will be held in Finnish.

Price:

A 2-day-course costs 1190 € per delegate. Price includes course material, breakfast, lunch and afternoon snack. This training will be pre-invoiced and the payment is required before the training. VAT 25,5 % will be added.

Registration:

Please register by February 21st, 2025 at the latest. 

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Takomotie 8,

00380,

Helsinki,

Finland