CE Mark for Medical Device - Ahmedabad, India

Medical Device Directive is one of the most complex directive and one which involves strict vigilance by the European Authorities. Steps for CE marking for Medical Devices of Class 1s , IIa, IIb and III are as follows http://cemarkcertification.in/cemarking/ce-marking-for-medical-devices-93-42-eec-and-2007-47-ec

Pressure Equipment Directive ( 97/23/EC) is applicable to all those equipmments which have a internal design pressure more than 1.5 bar. Design pressure is generally greater than maximum operating pressure http://cemarkcertification.in/cemarking/ce-marking-for-pressure-equipment-97-23-ec-and-2009-105-ec

It is mandatory to test your product according to applicable harmonised standards. While testing against EMC and RoHS directive is generally done against generic standards , the LVD directive however generally requires testing as per product specific standards http://cemarkcertification.in/cemarking/ce-marking-for-lvd-emc-2006-95-ec-and-2004-108-ec

Make sure that the machine is not falling under Annex IV of the machinery Directive. If it does involve a Notified Body . Apply most specific standard or EN 60204 if no machine specific standard is available. Remember to choose the lates version of the spplicable safety standard http://cemarkcertification.in/cemarking/ce-marking-for-machinery-2006-42-ec

It is important to identify the harmonised standard and procure it to look for the routes to certification menioned in that particular standard for that paricular product http://cemarkcertification.in/cemarking/ce-marking-for-construction-products-305-2011

RoHS 2 allows for CE marking for products complying with it .
The Restricted Substances list remains the same (lead, mercury, cadmium, Hexavalent chromium, Polybrominated biphenyls, Polybrominated diphenyl ethers)
Testing has to be done as per EN 62321:2009
Technical File has to be compiled as per EN 50581:2012
Additionally Guidance is given in IEC standards IEC /TR 62476 for How to evaluate the products and IEC/PAS 62596 for Guidance on sampling procedure. http://cemarkcertification.in/cemarking/rohs-certification

Unique Offer for EMC EMI testing not in thousands of USD but in hundreds
We undertake professional testing services under controlled environment for the following EMI EMC testing in just

675 USD or INR 40000 per product
http://cemarkcertification.in/cemarking/emc-emi-testing