Medical Device CE Marking


Yes. We support Usability Engineering documentation

The latest Medical Device software validation method (life cycle process model) developed is IEC 62304:2015 or ISO 62304. The new standard covers software development & maintenance, risk management according to ISO 14971, partitioning and safety classification of software items, and software process management. As per clause 3.12 of IEC 62304:2015, a Medical Device Software means “SOFTWARE SYSTEM that has been developed for the purpose of being incorporated into the MEDICAL DEVICE being developed or that is intended for use as a MEDICAL DEVICE in its own right”.

By supporting on attaining the CE mark and QMS implementation, consultants play very crucial roles in assuring CE certificate from the Notified Bodies.

Cost of testing as per the harmonized standard
Notified Body Fees including auditor travel
Consultants fees towards guidance and preparation of Technical File/Design Dossier
Annual Surveillance Audit
ISO 13485 Implementation and Certification Fee

In order to classify your product, the first step in EU regulatory process is determining which regulation is applicable to your product, that is, MDR 2017/745 or IVDR 2017/746. For the purpose of classification there are 22 rules in Annex VIII of the MDR

Classification are as follows:

Class I– Provided non-sterile or do not have a measuring function (low risk)
Class I– Provided sterile and/or have a measuring function (low/medium risk); the MDR adds reusable surgical instruments as Class I reusable surgical instruments, to this group.
Class IIa(medium risk)
Class IIb(medium/high risk)
Class III(high risk)


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