I 3 Consulting

August 14, 2018

Clinical Evaluation Report

An Informative article about Clinical Evaluation Report CER) as per MEDDEV 2.7/1 Rev. 4 Download the article here
March 17, 2018

Clinical Evaluation as per MEDDEV 2.7.1 Rev 4

Clinical Evaluation as per MEDDEV 2.7.1 Rev 4 Latest requirement to fulfill MDD compliance for Medical Device Manufactures!!!   Clinical Evaluation Reports (CERs) Preparing a clinical evaluation report (CER) is time consuming and always need the support of skilled consultants. A post-market surveillance plan for each medical device or device family that specifies the frequency of performing a review and update of your clinical evaluation report (CER). What are included in Clinical Evaluation Report? Published […]
December 16, 2015

FDA 510k & CE Marking

Medical Device Regulation in USA is formulated and controlled by FDA via Section 510k of the act. However, in Europe its via MDD directive so called CE Marking Reading this article will help those unfamiliar with 510k and  CE marking effectively prioritize their regulatory efforts. 510(k) is the preferred route to reach the Largest single market (USA) whereas CE Marking is the preferred route to reach 37 European counties and very interestingly it is widely accepted […]
November 16, 2015

Who is a Competent Authority and a Notified Body?

A Competent Authority is the body, which has the authority to act on behalf of the government of a member state to ensure that the requirements of the Medical Devices CE Marking directives are carried out in that particular member state. The European Union (EU) comprises 28 member states. Each member state is party to the founding treaties of the union and thereby subject to the privileges and obligations of membership. Notified Body is a […]