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

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...

read more

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...

read more
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...

read more