Challenges faced by manufacturers with clinical evaluation under the new European Medical Device Regulations

Author:

Kearney Breda1,McDermott Olivia1ORCID

Affiliation:

1. College of Science & Engineering, University of Galway, Galway, Ireland

Funder

no funding associated with this research

Publisher

Informa UK Limited

Subject

General Engineering,General Chemical Engineering,General Computer Science

Reference64 articles.

1. Al-Faruque F. (2023a). Council votes unanimously to extend MDR deadlines. RAPS . https://www.raps.org/news-and-articles/news-articles/2023/3/eu-council-votes-unanimously-to-extend-mdr-deadlin

2. Lean Six Sigma for higher education institutions (HEIs)

3. New EU medical device regulations: Impact on the MedTech sector;Behan R.;Medical Writing,2017

4. Memoing in qualitative research

5. Optimal database combinations for literature searches in systematic reviews: a prospective exploratory study

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