MEDICAL DEVICESThe Medical Device Technical-Regulatory Area of Bio Basic Europe provides producers and manufacturers with consulting services, assisting companies in the production of the technical documentation, necessary for obtaining the CE marking and for trading medical devices in EU and non EU countries.
Bio Basic Europe coordinates and monitors CLINICAL INVESTIGATIONS ON MEDICAL DEVICES of each risk class, managing the entire process, in accordance with EN ISO 14155 and ICH-GCP guidelines.
Below is a list of the main technical-regulatory services offered by Bio Basic Europe for producers and manufacturers of medical devices:
- Drafting of the technical documentation required to obtain the CE marking.
- National and international registration procedure for medical devices and assistance for marketing and set-up activities.
- Contact management with National and International Notified Bodies and competent Authorities.
- Logistic support: contacts with customs and preparation of the documents necessary for EU/non-EU import/export.
- Drafting, editing and updating of:
- Technical files
- Design Dossiers for class III medical devices
- Risk Management Plan, Analysis and Report
- Clinical evaluation reports (CER)
- Documentation supporting the absence of FIM action of a medical device
- Theoretical assessment of the toxicological profile of a medical device
- Rationale of the tests performed on a medical device, in order to give evidence of a "stepwise" approach, as described in the ISO 10993-10 standard
- Post-market surveillance and post-market clinical follow up, according to the provisions of Directive 93/42/ EEC, Regulation 2017/745 (EU) and other relevant laws
- Substitute declarations in accordance with horizontal and vertical sector regulations
- Coordination and monitoring of CLINICAL INVESTIGATIONS on medical devices of each risk class, in accordance with EN ISO 14155 and ICH-GCP guidelines. Assistance with the stipulation of insurance policies.
- Advisory services for labelling and instructions for use.
- Consultancy concerning the legislation governing printed/advertising material.
- Paperwork for advertising/scientific information.
- Contacts with ISO/IEC 17025 accredited laboratories.
- Amendments, renewals, extensions, following the registration phase of the medical device.
- Consulting services to companies in their certification process, and drafting of the documentation necessary for the fulfilment of the certification offer (forms, rational of the mechanism of action, etc.).
SKIN IRRITATION CLINICAL MONITORING
SAFETY AND EFFICACY LABORATORY TESTS