Documentation Preparation, Consultancy

ISO 9001 is the most generic Quality Management System which can be applied to any industry. Organization going for the ISO 9001 certification for various reasons, such as for internal improvement, to fulfill customer requirements, market branding etc.

ISO 14001 is the Environmental Management System (EMS), the ultimate aim for this standards is to achieve the environmental objectives, enhance the environmental performance and fulfills the compliance obligations.

GDPMD is the Regulatory requirements for Medical Device Safety & Performance. In the Medical Devices Regulation 2012, Appendix 4 – Requirements on the Quality Management System, it specifies that Authorized Representative, Importer and Distributor is required to certify under GDPMD.