Regulatory Operations

Are you ready? Preparing for the new EU MDR implementations

New regulations are in effect, with transition periods ending in 2020 and 2022 Medical and in vitro diagnostic device manufacturers in the EU are likely aware of big changes in…

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RIM as a load-bearing wall for regulatory compliance

“RIM provides an integrated view of regulatory information.” “Affiliates and regions should play a key role in the system.” “RIM is the foundation of the future IDMP implementation.” The quotes…

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Managing Regulatory Operations from a Compliance Perspective

Co-authored by Aubrey Elmore, Senior Consultant PCMA By the year 2025, the government-sponsored share of health spending is projected to increase and account for 47% of national health care expenditures,…

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