Regulatory Consultants

Level Up Your Business With OMC Medical

Services

Performance

A regulatory approach that focuses on desired, measurable outcomes.

Strategy

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

Marketing

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

February Newsletter

February Newsletter

EUROPEAN UNION (EU) MDCG guidance on vigilance terms and concepts of EU MDR | 14 February 2023 The MDCG 2023-3 guidance document clarifies some of the essential terms and concepts in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR)....

read more

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