I. Quality Management EN ISO 13485:2016
em-tec GmbH maintains a quality management system certified according to DIN EN ISO 13485:2016 (certified through TÜV Süd Product Service GmbH). This ISO standard defines the requirements for a comprehensive quality management system that meets the highest demands of medical technology. em-tec's quality management system covers the areas of design, manufacturing, sales of and service of medical products and also covers the contract development of those products.
II. International Approval and Certification of Medical Products
em-tec GmbH possesses profound knowledge of European and extra-European approval processes as well as of the regulatory specifications for medical and industrial products.
EU Directive 93/42 EEC: The Medical Device Directive (MDD) is the most important regulatory instrument to verify the safety and technical performance of medical devices within the European Economic Area.
EU Regulation 2017/745 (MDR): This regulation replaces the Medical Device Directive (MDD) 93/42/EEC and the Active Implantable Medical Devices Directive (AIMD) 90/385/EEC by defining modified requirements for the manufacturing and distribution of medical devices (including technical documentation, post-market surveillance, labelling [UDI] and classification).
EU Directive 2014/30/EU: The EMC directive specifies how the electromagnetic compatibility of electrically run devices within the European internal market is meant to be designed.
EU Directive 2015/863/EU (RoHSIII): The EU directive RoH III serves to limit the use of certain hazardous substances in electrical and electronic devices and regulates the use and the market authorization of hazardous substances in electrical devices and electronic components.
21 CFR 820 (GMP, US-FDA, quality management): Requirements for the quality management of manufacturers of medical products that export to the USA (Good Manufacturing Practice for Medical Devices/ GMP).
JQMS (confirmation letter): regulatory specification for manufacturers of medical products for the Japanese market.
III. Advisor and Development Partner
Based on decades of experience, we are happy to support you on your development projects as well as any questions regarding risk management and normative requirements (e.g. ISO 13485, ISO14971, DIN EN 60601, IEC 62304, FDA requirements, MDR). We accompany you before, during and after audits performed by customers, notified bodies or administrative bodies and support you in regard to documentation (e.g. clinical evaluations, market supervision).
On request, we are also happy to offer training concerning QM&RA or project-based topics.
The application life cycle management software tool we work with to support development, verification, requirements management and document generation is „Polarion".
Risk Management DIN EN ISO 14971: Standard for the application of risk management on medical products. This norm requires a risk analysis, risk evaluation as well as risk control throughout all phases of a medical product's life cycle.
Standard 60601-1: Body of standards for electrical medical products. Electrical/ mechanical safety, marking and labeling, as well as the life cycle process of medical, electrical devices are processes within those norms. Moreover, this is where regulations concerning the minimization of risks stemming from electro-magnetic radiation and exceeding temperatures can be found. It also includes a description of the requirements for a medical product to fulfill the specifications for electromagnetic compatibility.
IEC62304: Standard for the software for medical devices. It shows the minimal requirements for the most important software life processes (development, maintenance, risk management, configuration, problem solution).