DRSConsult as Group of Experts offers you a wide range of international support in the field of Medical devices:


Support in the field of Medical Devices concerning regulations and international standards for active devices ( IEC 60601 family), Risk management (ISO 14971:2012), Biocompatibility studies (ISO 10993 series), Clinical evaluation (ISO 14155, MEDDEV 2.7.1. rev 4) and quality systems (ISO 13485:2016), sterilization processing and sterility

Auditing and Quality management

Support in Audit-planning and conduction for OEM-producers and suppliers concerning Quality assessments and quality survey – Audits related to ISO 13485, IEC 62304, IEC 82304, ISO 27001

Production / Outsourcing

Support of Production Outsourcing of existing products to Asian suppliers (OEM and Non-OEM)- Planning of new production lines and complete production areas (clean room production) Product survey on Chinese market – Safety evaluation of product protection on Chinese market.

Development of new Medical devices

Support of Development and documentation concerning the development of new products, Regulatory and clinical strategy planning worldwide – Product protection planning for different markets worldwide.