The sanitary products, which are not custom-made products or those under investigation, will carry the CE conformity marking to show compliance with current directives and shortly with the Regulations so that they can circulate freely within the European Union and can be placed in service according to its intended purpose.
QUALIPHARMA MEDICAL DEVICES provides you with customized solutions for:
- Strategy for the classification of Health Products.
- Obtaining the CE Marking in Europe.
- Definition of the General and Operating Requirements.
- Risk Management and Analysis according to EN ISO 14971.
- Clinical evaluation report (CER MEDDEV 2.7.1 Rev.4).
- Biocompatibility report (biological safety).
- Support in search of Accredited Laboratories to carry out electrical safety tests and electromagnetic compatibility for electromedical equipment and systems.
- Preparation of technical documentation (Technical File).
- Advice on labeling and promotional materials.
- Verification and Validation of Software and Apps.
- Validation of manufacturing processes
- Placing the product on the market.
- Activities license (manufacturing, import, distribution and sterilization).
- Selection of the Notified Body and interlocution to resolve deficiencies.
- Advice on the performance of preclinical and clinical trials.