To achieve regulatory compliance and authorization for sale in Europe, every medical device must be supported by a Clinical Evaluation Report which documents the entire clinical evaluation process.

Steve Cottrell, President at Maetrics, comments: “Effectively managing Clinical Evaluation Reports is vital to achieving successful compliance for the new MDR.

The International Medical Device Regulators Forum (IMDRF) recently released three final documents on clinical evaluations, clinical investigations and clinical evidence for medical devices, replacing ...

Mentavi’s innovative online asynchronous assessment, validated in a clinical study presented at the 10th World Congress on ADHD, provides clinicians with an efficient, comprehensive diagnostic mental ...

This medical device webinar will discuss strategies for meeting the Post Market Surveillance requirements as described in Annex X of the MDD (MDD 93/42/EEC, updated per the 2007/47/EEC M5 amendment, ...

Writing Effective Clinical Evaluation Reports as Part of Post-Market Surveillance 24 January 2014, Palo Alto, United States ...