Regulatory Consultants

Level Up Your Business With OMC Medical



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

Let’s Chat!

Why Us

50+ companies trust us. 20+ years of experience in the regulatory field.

Learn More

Weekly Regulatory Updates/Resources

Follow us on

November Newsletter

EUROPEAN UNION (EU) EU guidance on reference laboratories for IVD medical devices | 30 November 2022 EU Commission has published new guidance for candidate reference laboratories in the In vitro diagnostic medical devices field. The document guides laboratories...

read more

October Newsletter 2022

EUROPEAN UNION (EU) Guidance on EU Authorized Representatives | 31 October 2022 Medical Device Coordination Group has updated its guidance on Authorized Representatives under MDR 2017/745 and IVDR 2017/746. Under both MDR and IVDR, it is a requirement for...

read more

September Newsletter 2022

EUROPEAN UNION (EU) Notified Bodies Position paper on application of hybrid audits for QMS assessments under MDR and IVDR|26 September 2022 The latest position paper discusses the need for hybrid audits instead of the traditional on-site audits which were previously...

read more