Lisa Madison

2 d - Translate

The European Union officially released the In Vitro Diagnostic Regulation (IVDR) in 2017, replacing the previous In Vitro Diagnostic Directive (IVDD). The IVDR came into effect in May 2022, but the European Parliament approved a proposal in April 2024 to extend the transition period, with the longest extension possible until 2029. https://www.proregulations.com..../eu-in-vitro-diagnos

EU In Vitro Diagnostic Regulation (IVDR) Registration - Proregulations

Proregulations provides comprehensive EU IVD regulation compliance services to ensure that your products comply with the latest regulatory requirements and obtain the CE mark.

Comment

2 d - Translate

510(k) is a premarket technical document submitted to the FDA before a product enters the U.S. market to demonstrate that the product has the same safety and efficacy as a legally marketed comparable product in terms of intended use, design, materials, implementation standards, etc. https://www.proregulations.com..../u-s-medical-device-

U.S. Medical Device 510(k) Premarket Notification - Proregulations

Proregulations provides a range of U.S. medical device 510(k) premarket notification services to help customers reach their goal of selling in the U.S. market as quickly as possible.

Comment

created a new article

2 d - Translate

Proregulations Launches Strategic Approach for Achieving ASMF Compliance | #asmf Compliance

Proregulations Launches Strategic Approach for Achieving ASMF Compliance

Proregulations, a leading provider of product consulting and regulatory compliance solutions, launches a strategic approach for achieving ASMF compliance.

Comment

2 d - Translate

EU In Vitro Diagnostic Regulation (IVDR) Registration - Proregulations

2 d - Translate

U.S. Medical Device 510(k) Premarket Notification - Proregulations

2 d - Translate

Proregulations Launches Strategic Approach for Achieving ASMF Compliance

Language