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Regulatory Globe|2 December 2020

Regulatory Intelligence Paper

Remain informed about upcoming rules, regulations, guidance, and standards.

Remain informed about upcoming rules, regulations, guidance, and standards.

According to the new MDR, IVDR, and ISO 13485:2016, it is required and important to be up to date with all the regulatory requirements. Our Regulatory Intelligence Paper precisely pursues this goal. You will receive monthly updates from us from the most important countries. The paper itself is structured as a decision tree so that you can quickly see what the new requirements are, which economic operators and products are affected, and when the implementation deadline is. In this way, you can assess in seconds whether this new requirement is relevant or not. Your decision can be documented directly on this paper and be used as part of the management review as required by ISO 13485:2016.

What you get:

  • Receive every month for one year our Intelligence Paper – (12 editions)
  • Focus on all MDSAP countries (USA, Canada, Australia, Brazil, Japan) and EU
  • Instruction for Use
  • Technical Support

Benefit:

  • Ideal to use for management review according to ISO 13485:2016, chapter 5.6
  • Saving you a lot of research hours
  • Be always informed about regulatory changes
  • Stop to be reactive and start to be proactive
  • Strong focus on regulations, guidance and standards
  • Focus on MDSAP + EU countries
  • Inclusive decision tree

Always be aware and prepared for your next audit.

(ISO 13485:2016; Chapter 5.6 Management Review).

For manufacturers who are not established in the Union, the EU Authorised Representative plays a pivotal role in ensuring the compliance of the devices produced...
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