Elk Rock Consulting is located in Zeist, the Netherlands and provides the following consultancy services for the CE marking of Medical Devices. · MDR - EU Medical Device Regulation (2017/745/EU) · MDR article 15 - External PRRC (Person Responsible for Regulatory Compliance)for small and micro enterprises (definition: Commission recommendation 2003/3761/EC) · QMS - ISO 13485 Quality Management Systems for Medical Devices