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

June Newsletter 2023

June Newsletter 2023

EUROPEAN UNION Implementation of Regulation (EU) 2023/1194 on transitional provisions for products without an intended medical purpose | 21 June 2023 The deadlines for Annex XVI products mentioned in Implementing Regulation (EU) 2022/2346 has been extended in the...

read more

May Newsletter 2023

EUROPEAN UNION (EU) Updated MHRA guidance on significant changes under MDR | 12 May 2023 The guidance document MDCG 2020-3 Rev.1 is intended to clarify the concept of ‘significant changes in the design and intended purpose’ under Article 120(3c), point (b) MDR. It...

read more

April Newsletter 2023

Germany Database for In vitro diagnostics Medical Devices notification | 25 April 2023 In Vitro Diagnostic Medical Devices Notifications includes notifications on the first placing of in vitro diagnostics on the market (according to § 25 MPG - Act on Medical Devices)....

read more