Technical Documentation of Medical Devices
CE Marking of Conformity Class lla, llb, lll

Prerequisite for the acquisition of CE mark for medical devices in accordance with the requirements of the Regulations MDR 2017/745 and MDR 2017/746:
- recognition of the required legislation, specifications as well as the requirements set by the products
- redaction of technical documentation of the product
- search for suitable laboratories to carry out the laboratory tests of the products (whenever is required) and the coordination of audits
- search and collaboration with the Notified Body for the examination of technical documentation and for the issuance of the certification of compliance (CE MARKING )
- definition of Person Responsible for Regulatory Compliance (new regulation of the medical products MDR /745
- making hearing aid molds
- manufacturing of orthopedic aids
- construction of orthotic insoles
- manufacturing of hospital equipment
- manufacturing sterile surgical tools (surgical talus burr)
- construction of a water treatment unit for hemodialysis treatment
- construction of dental aspirators
- manufacture of surgical sutures (class IIb and III)