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A global medical technology company engaged ECLEVAR to support them to improve the CER procedures. Initially called on ECLEVAR to provide a gap analysis of their CERs and CER processes (time to complete, rotation of CERs coming up for renewal, literature review process etc.).
This initial review led to ECLEVAR being commissioned with 9 CERs to complete within a short 3 month window which would have been impossible to achieve internally.
A further 13 CERs were commissioned and an entire rationalisation of the CER process undertaken. This also led to conversations about consolidating devices under a single CER and to preparing an approach on prioritisation of CERs.
The results of the new processes implemented by ECLEVAR for the med tech company were immediately noticeable. Not only did ECLEVAR meet the tight delivery deadline, the company can also boast of no failed CERs. Looking forward, this leading medical technology company has up to date, standardized procedures and can enjoy greater efficiencies in processing CERs as they come up for review.
Twelve (12) months ago, the EU Commission published a Notice to Stakeholders, “Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products,”Read More..
ECLEVAR invites you to meet with us at MedTec Japan in Tokyo, Japan on 18-20 April.