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A regulatory approach that focuses on desired, measurable outcomes.


Strategy to bring a new or modified medical device product to market.


The regulatory laws that protect consumers from being misled or lied to by businesses

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Weekly Regulatory Updates/Resources

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July Newsletter 2022

EUROPEAN UNION (EU) Harmonised administrative practices and alternative technical solutions| 13 July 2022 The MDCG guidance document advises the Member States and other relevant parties on applying specific IVDR regulations in the absence of Eudamed. This guidance...

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June Newsletter

  EUROPEAN UNION (EU) Guidance document on the implementation of EU product rules 2022 | 29 June 2022 The ‘Blue Guide’ on EU product rules 2022 (Document Number (2022/C 247/01). This guidance discusses both non-food and non-agricultural products, referred to as...

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May Newsletter 2022

May Newsletter 2022

EUROPEAN UNION (EU) Stricter rules for placing medical tests on the market | 25 May 2022 From 26 May 2022, new laws for in vitro diagnostic medical devices (IVDR) such as HIV testing, pregnancy tests, and COVID-19 tests are in effect. The guidelines will improve...

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