When manufacturing of medical products is involved, a company has a special responsibility. Therefore quality is an essential component of all processes for us. Through the close and effective cooperation between all the departments, it is possible to guarantee the highest quality standards.
Our certified quality management system makes it easy to obtain the CE approval, we also like to perform on behalf of our customers. In addition, complete traceability and process documentation are just as natural for us as a continuous measurement and test equipment.
DITABIS supports you with your product certification (IVD/FDA). DITABIS follows international standards and rules from authorized certification companies in Germany and other countries. Only certified products can open you the way to new markets all over the world. There is no product in Germany and Europe where you don´t have any regulations.
Furthermore DITABIS is developing and producing medical instruments and has the practical experience in certifications.
The first placing in the market of medical equipment is covered by extensive regulatory requirements and a new edition or modification of standards demand reassessment and possible adjustment of safety checks to obtaining certification of conformity.
- CE Conformity
First Marketers bear responsibility that requirements regarding Medical Devices Act (EU directive medical-technical products MDD 93/42/EEC) and In-vitro-diagnostic medical devices (EU directive 98/79/EG are met and products are labelled with a CE mark. DITABIS assists you in complying with these standards.
The services of DITABIS includes:
• Assistance in compiling and verifying of technical documentation regarding CE conformity
• Assistance in compiling and checking of a design dossier
• Verification of essential requirements
• Product classification and identification of applicable standards for medical products
• Review of product authentication and packaging
- Risk Management
Risk management consists of established processes to eliminate or reduce risks by means of
conceptual and design measures. DITABIS takes care that requirements regarding risk management in accordance with DIN ISA EN 14791 are met during the entire life cycle of the product, from development through application and disposal.
- CB Report
DITABIS offers assistance and technical support with CB certification and with obtaining the CB report and the CB certificate according to a harmonized standard such as IEC 61010, IEC 60950, IEC 60065 and others. A CB certification facilitates international trade with electro technical products and international authorization procedures and secures compliance with applicable requirements.
- EMC Tests
Tests of the electromagnetic compatibility (EMC) of your laboratory and medical equipment assures
compliance with limits regarding emission and immunity. DITABIS assists with experience and technical support regarding the elimination of interferences of your laboratory and medical products.
- US FDA Certification
You require assistance with international regulatory questions, e.g. the US market? DITABIS offers services in the framework of an investigation and categorizes essential FDA requirements, be it laser safety and laser radiation protection or the filling-out of extensive product reports, we support your efforts.
If you want to have support for the certification of your medical system, then please get in contact with us: busdev(at)ditabis.de
DITABIS is a certified company and we follow very high quality rules.
ISO certificates for our quality management system