CE marking consultancy for medical device certifications
Medical Consulting S.r.l.s. carries out consultancy and support activities for manufacturers and interested economic operators to obtain the CE marking in full compliance with the requirements of EU Regulations 2017/745 (MDR) and 2071/746 (IVDR).
The Medical Consulting staff is adequately and constantly trained on the news relating to the directives, regulations, guidelines and common specifications of reference.
The main consultancy activities for the CE marking consist of:
- Consultancy for the design of new medical devices and feasibility analysis to verify the possession of the general safety and efficacy requirements necessary to obtain the CE marking
- Gap-analysis / guidelines / document pre-screening for the adaptation of the related product and system Technical Documentation.
- Drafting / support for the drafting of Technical Documentation and related System documentation
- Definition and implementation of the Risk Management process (reference ISO 14971)
- Definition and implementation of the post-market surveillance process (PMS plan and report, PSUR, Periodic Safety Summary and Trend Analysis).
- Drafting and updating of CEP (Clinical Evaluation Plan), CER (Clinical Evaluation Report) and PMCF (Post Market Clinical Follow-up) according to MDR and IVDR
- Support in the design and execution of clinical trials
- Interpretation and application of product standards
- Identification of device qualification tests
- Identification of the validation tests of critical processes
- Assistance during the Audits of the Certification Body
- Definition and implementation of the UDI system
- Registration of medical devices in the Italian “Medical Device Database”
- Registration of Economic Operators and devices in the European database Eudamed
Consultancy and support service for obtaining the necessary certifications for the European Community and for non-European countries
- Consulting and support service for the obtainment of certification required for the European Community and non-European countries.
- Consulting services for the recording of medical devices and Economic Operator in Eudamed database.
Contact with Authorities
- Drafting of technical dossiers for obtaining CE certification
Training and support
Support, consultancy and training activities for start-ups in the field of medical and implantable devices, with a vertical approach that favors specific focuses on the topics
Audit and support
- Audits at medical device and implant distribution companies
- Specific consulting relating to product development or marketing strategy plans
- Collaboration and participation in the development of start-up projects in the medical-surgical device and implant sector
- Training courses relative to developed Products
- Training courses for sales networks