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.
All timeline stories.
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
