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ISO 13485 MDR Internal Auditor

  • Location

    Helsinki, Finland

  • Start

    06. Sep 2023

    9:00 AM

  • End

    07. Sep 2023

    5:00 PM

  • Time Zone

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

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SGS Academy in Finland will organize a training

ISO 13485 and MDR Internal Auditor (2 days)

Date and location:

September 6th – 7th, 2023

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 24 % will be added.

Registration:

Please register by August 22nd, 2023 at the latest.

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Takomotie 8,

, 00380,

Helsinki,

Finland