Translation of technical documentation
Technical translation - Complex multilingual projects – This is exactly our thing Naturally...
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Test lab services for the medical device...
The components and devices we manufacture must stand up to unrelenting physical, biological and chem...
Medical technology translations
Medical technology translations Our communication specialists have linguistic as well as technica...
Metrological control of digital sphygmomanometers
Metrological control of digital sphygmomanometers Metrological control (MtK) on digital sphygmomanom...
HAMER blister sealing machine HMS 50
HAMER blister sealing machine HMS 50 The HMS 50 blister packaging machine is a semi-automatic...
IVD Engineering Solutions - Custom Solutions
DIALUNOX Engineering Services - You have the Idea - we develop your product Custom Solutions D...
Injection molding advantages for medical...
We have been successfully developing and manufacturing plastic parts and assemblies for medical tech...
Our experience ranges from all kinds of written material for clinical studies (recruitment, marketin...
technology Majesty relies on the innovative and future-proof .net technology from Microsoft. A po...
Verification and validation of software in...
Our experience in a variety of safety-critical areas enables us to deliver an effective and efficien...
Risk Management & Regulatory Affairs
Risk Management & Regulatory Affairs Regulations standardise the rules for manufacturers and...
oxaion easy medical technology - the business...
Smaller companies in medical technology in particular are feeling the pressure exerted by the new DI...
Metrological control of manual sphygmomanometers
Metrological control of manual sphygmomanometers Metrological control (MtK) on manual blood pressure...
Biological Safety Testing of Medical Devices
Biological Evaluation of Medical Devices / Biocompatibility TPMD provides a highly sophisticated...
Repair service for SpO2 sensors
We offer you various repair and service services for SpO2 sensors Repair service for your SpO2 se...
Development of Medical Devices - Systems...
Software Development We work in each phase of the medical devices’ development lifecycle an...
UDI code verification according to ISO15415...
Verification means providing evidence that a fact is true. Using the UDI code verification in accord...
Quality-verification processes for the medical...
No industry faces a higher mandate for quality than medical device manufacturing. At ADMEDES, we und...
Cyber security for medical devices and medical...
Cyber Security The security of embedded devices is a pressing concern for society. Medical dev...
Contract Packaging and Sterilization for...
Contract Packaging and Sterilization of Medical Products From raw material to ready-to-...
Safety checks and maintenance service on...
Safety checks on pulse oximeters We test your pulse oximeter including SpO2 sensor from the followin...
Checking the health of medical devices
A staggering one in three medical devices have suffered recalls because of failures – with sof...
With modern equipment, we can label your products precisely and in a validated manner. To implement...
All quality-relevant data is shown centrally on the respective drawing. It can be a 2D or 3D drawing...
Qualified AM - Bridging Innovation and Compliance
Bridge the gap between innovation and compliance We certify on an equal footing and offer a colla...
Tests as part of the validation of instructions...
Manufacturers and distributors of medical deviceswhich are designed for reuse, must provide informat...
EN ISO 13485 web documentation
Record changes on the website (can be used for EN ISO 13485) The DIN EN ISO 13485 is a quality ma...
Safety checks and DGUV4 tests We test your devices according to DIN VDE 0751 / DIN EN 60601-1 / D...
Medical Clean room plastic injection
Medical technology clean room injection molding We manufacture plastic components in the clean ro...
Case Study: Arterial Blood Collection Vessels
Whole blood samples are taken from patients using arterial blood collection vessels. The sample is t...
UDI as part of the business software in medical...
Not least because of the MDR, the UDI is developing into an essential component of overarching busin...
Tests as part of the validation of instructions...
In the same way as with processing of medical devices (cleaning and disinfection) the manufacturer o...
Patent translation Your intellectual property is valuable. We help you to protect it internationa...
R&D / LAB ANALYTICS Through our own laboratoy, we can offer a decisive benefit to our custome...
Localisation of Medical Software
Software localization Software localization – developing and adapting software, online help...
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Eurofins Inpac Medizintechnik GmbH (EN)
75217 Birkenfeld, Deutschland
PAYER International Technologies GmbH (EN)
8151 St. Bartholomä, Österreich
78549 Spaichingen, Deutschland
PROMOTEC-Medizintechnik GmbH (EN)
15827 Blankenfelde-Mahlow, Deutschland
78532 Tuttlingen
76275 Ettlingen, Deutschland
Kunststoff Christel GmbH & Co. KG (EN)
78073 Bad Dürrheim, Deutschland
75179 Pforzheim, Deutschland
85092 Kösching, Deutschland
add'n solutions GmbH & Co.KG (EN)
78532 Tuttlingen, Deutschland
78532 Tuttlingen, Deutschland
1 - 38 by 38 results
QM & RA of the area General Services for the MedTech Industrie
Products and services from the categories Quality Management (QM), Regulatory Affairs (RA), testing, etc. for medical technology in medical technology or other healthcare-related industries .
Quality Management (QM) for medical technology, Quality Management (QM) for the pharmaceutical industry, Quality Management (QM) laboratory technology, Regulatory Affairs (RA) for medical technology, Regulatory Affairs (RA) for the pharmaceutical industry, Regulatory Affairs (RA) laboratory technology, Tests for medical technology, tests for the pharmaceutical industry, tests for laboratory technology, tests for medical technology, tests for the pharmaceutical industry, tests for laboratory technology, audits for medical technology, audits for the pharmaceutical industry, audits for laboratory technology
Many people are aware of the differences between Quality Management and Regulatory Affairs, but they don't know exactly how these two areas relate to each other. Though the two are often discussed in the same breath, they are actually two very different fields. This article aims to shed some light on the relationship between the two and offer insights into what they involve. In particular, it will provide insight into the different requirements each field has for its professionals.
UL is a global medical device consulting company. The combination of their services will help medical device companies bring their products to market faster. The companies will also help the companies develop higher-quality processes. The bundled offerings are designed to support the needs of medical device manufacturers. In particular, Greenlight Guru, a leading MDQMS platform, has partnered with EMERGO by UL, the world's leading consulting firm for global medical device regulatory compliance.
Greenlight Guru is a medical device consulting firm that offers a cloud-based MDQMS platform for MDQMS. EMERGO by UL offers an industry-leading QMS solution, along with a regulatory affairs management suite. The MDQMS platform enables closed-loop traceability of product quality, which accelerates product development activities. And UL's Regulatory Affairs Management Suite (RAMS) provides digital tools for managing registration and certification documents.
Steffen Rauschenberger is MEDIRA's Head of Quality Management and Regulatory Affairs. He has more than 20 years of experience in the development of implantable, non-active medical devices. Before joining MEDIRA, he worked as a project manager and head of quality and regulatory affairs at JOTEC GmbH. He holds a diploma in general and analytical chemistry from Reutlingen University of Applied Sciences.
Regulatory affairs is an important area for any medical device company. Regulatory compliance involves ensuring that the product is safe and effective. In addition to the safety and efficacy of a medical device, it must meet FDA and European Commission standards. The regulatory agency, the FDA, a manufacturer must follow ISO 13485:2016. This standard is aligned with FDA's term "device" and requires a technical file of the product.
The FDA has outlined quality guidelines, each designated by a letter and a number. The FDA has published guidelines for cGMP compliance, which include requirements for finished pharmaceuticals. Industrial automation systems have allowed companies to record process variables automatically. The advantage of this automated recording is that the data is highly accurate and is more resistant to tampering. Electronic records are also considered to be a part of a drug's regulatory compliance.
The two departments are intertwined. Regulatory affairs is concerned with ensuring that products comply with government regulations. Similarly, quality assurance focuses on ensuring that a product meets the standards that the government set. The two departments work together to ensure the quality of a product. The role of a QA director is to oversee the process of compliance and develop the necessary processes. A QA director will be responsible for developing and maintaining a quality control system.