The EU Medical device regulation (MDR 2017/745) was published on 5 April 2017, replacing the two existing directives, the Medical Devices Directive
The transition period ends on May 25, 2020.
What we can offer you:
• Gap analysis MDD-MDR
• Technical documentation compilation
• Technical documentation review
• Classification of your medical device
• Identification of Route to Conformity
• Risk Assessments / Risk Management Files to EN ISO 14971
ISO 9001 and ISO 13485 are an effective solution to meet the comprehensive requirements for a Quality management system.
Both QMS standards connected, ISO 13485 is based on ISO 9001 process model.
In March 2019, the new ISO 13485:2016 will be mandatory.
EU Authorized representative means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive.
Medical devices - Application of risk management to medical devices ISO 14971:2007
ISO 14971 specifies a process for a manufacturer to identify the hazards associated with medical devices - to estimate and evaluate the associated risks, to control the risks, and to monitor the effectiveness of the controls.
We can offer you help with identification and evaluation of risks, what does ISO 14971 require, risk management planning, we can provide