All timeline stories.

FDA Acceptance of ISO 594-1/-2 & ISO 80369-7:2016

FDA removes withdrawal date of ISO 594-1/-2 and announces the acceptance of ISO 594-1/-2 and ISO 80369-7:2016 as consensus standards until the second of ISO 80369-7 is published.

Compliance Testing

Merit starts dimensional and functional testing on PRIORITY PRODUCTS


Modifications & Qualifications

Merit starts to modify and qualify molds to meet the specific design requirements in the standard

Second Edition of ISO 80369-7

The International Standards Organization starts development of second edition of ISO 80369-7, that will replace ISO 80369-7:2016.

ISO 80369-7:2016 Compliant Products

Merit certifys compliance to ISO 80369-7:2016 for some priority products. 

Merit Forms Internal Team

Merit forms a team of engineerings and regulatory professionals to start this compliance project

Dimensional Testing Equipment

Merit obtains and qualifies new State-of-the-art VISION SYSTEM for dimensional testing requirements

ISO 80369-7

The new Intravascular or Hypodermic Standard is published