Regulatory Affairs Consulting

One of our main areas of expertise is the Regulatory Affairs Consulting.

We cover  the full range of technical regulations and standards requirements including the Medical Device Directive, EMC , LVD, ATEX, EMC and Machinery Directive requirements.

We also cover the full in-country requirements and have assisted in our clients in achieving compliance in global markets including Australia, Russia and CUTR Countries, Japan, China, Korea. USA and Canada and the EU.  

We also provide conformity assessments on new product introductions to advise clients on their in-country requirements with respect to software registration,  labelling, power supply, battery and wireless conformity assessment plans, shipping requirements and technical file constructions requirements.     

We can also provide you the following services:

Commercial BER and DEC

SAP GTS consulting