All types of medical devices need to be safe and meet performance requirements. EU Regulatory Authorities require corroborating clinical evaluation to be included in your product’s technical documentation. Note that this applies even to devices that have been on the market for a long time.
CROMSOURCE will assist you with many aspects of the clinical evaluation process, including:
- scoping and identification of clinical data
- examining claims made about the device
- identifying equivalent devices on the market
- carrying out a comprehensive literature search
- writing a systematic literature review
- collating data from clinical investigations
- reviewing product complaints
- appraising and analysing all clinical data
- determining any need for Post Market Clinical Follow-up studies
CERs are prepared for you by CROMSOURCE in accordance with MEDDEV 2.7.1 Rev. 3, MEDDEV 2.12.2 Rev. 2 and your company’s own operating procedures.